Calibration methods for medical appliance tools

ABSTRACT

A method for operating an accessory device to capture calibration data. The method can include capturing an image of a portion of a user&#39;s body that includes the user&#39;s stoma and at least two reference locations, and storing distance scale information representative of a distance between the two reference locations. The method further includes processing the captured image, including: identifying the reference locations, identifying the stoma, and generating calibration data representative of one or more stoma parameters as a function of the identified reference locations, identified stoma and the distance scale information. The calibration data can be stored.

The present disclosure relates to an ostomy system, devices thereof andmethods for monitoring an ostomy appliance. In particular, the presentdisclosure relates to methods and devices for generating calibrationdata that can be used by accessory devices and methods in connectionwith cutting holes in ostomy appliances and guiding the placement ofaccessory devices on users.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated into and a part ofthis specification. The drawings illustrate embodiments and togetherwith the description serve to explain principles of embodiments. Otherembodiments and many of the intended advantages of embodiments will bereadily appreciated as they become better understood by reference to thefollowing detailed description. The elements of the drawings are notnecessarily to scale relative to each other. Like reference numeralsdesignate corresponding similar parts.

FIG. 1 illustrates an exemplary ostomy system,

FIG. 2 illustrates an exemplary monitor device of the ostomy system,

FIG. 3 is an exploded view of a base plate of an ostomy appliance,

FIG. 4 is an exploded view of an exemplary electrode assembly,

FIG. 5 is a proximal view of parts of a base plate,

FIG. 6 is a distal view of an exemplary electrode configuration,

FIG. 7 is a distal view of an exemplary masking element,

FIG. 8 is a distal view of an exemplary first adhesive layer,

FIG. 9 is a proximal view of the first adhesive layer of FIG. 8 ,

FIG. 10 is a distal view of a part of the base plate including monitorinterface,

FIG. 11 illustrates an exemplary accessory device in connection with theostomy appliance for performing various functions,

FIG. 12 illustrates the accessory device of FIG. 11 used in connectionwith the ostomy appliance,

FIG. 13 illustrates the ostomy appliance being applied to a stoma of auser,

FIG. 14 is an exemplary screen of the accessory device of FIG. 11depicting a perimeter of the stoma,

FIG. 15 is an exemplary screen of the accessory device of FIG. 11depicting a virtual stoma with indicia,

FIG. 16 is an exemplary screen of the accessory device of FIG. 11depicting a stoma-receiving opening of the base plate,

FIG. 17 illustrates the ostomy appliance applied to the user's stoma,

FIG. 18A is an exemplary screen of the accessory device of FIG. 11depicting a stoma location representation relative to a location of anostomy bag,

FIG. 18B is an exemplary screen of the accessory device of FIG. 11depicting a stoma location representation relative to a location of thebase plate,

FIG. 19 illustrates the accessory device of FIG. 11 capturing an imageof the stoma with reference locations,

FIG. 20 is an exemplary screen of the accessory device of FIG. 11depicting the stoma with reference locations on the user's body,

FIG. 21 is an exemplary screen of the accessory device of FIG. 11depicting the stoma with reference locations on the ostomy appliance,

FIG. 22 is a flowchart illustrating an exemplary method of a cuttinghole in the ostomy appliance,

FIG. 23 is a flowchart illustrating an exemplary method of placing theostomy appliance on the user, and

FIG. 24 is a flowchart illustrating an exemplary calibration method forthe ostomy appliance.

FIG. 25 is an exemplary graphical representation of parameter data as afunction of time,

FIG. 26 is an exemplary graphical representation of parameter data as afunction of time,

FIG. 27 is an exemplary graphical representation of parameter data as afunction of time,

FIG. 28 is an exemplary graphical representation of parameter data as afunction of time and a whitening zone diameter as a function of time,

FIGS. 29A-29B are exemplary graphical representations of peel force as afunction of a peeling distance travelled by a peeling action exercisingthe peel force on a first adhesive layer of a base plate.

DETAILED DESCRIPTION

Various exemplary embodiments and details are described hereinafter,with reference to the figures when relevant. It should be noted that thefigures may or may not be drawn to scale and that elements of similarstructures or functions are represented by like reference numeralsthroughout the figures. It should also be noted that the figures areonly intended to facilitate the description of the embodiments. They arenot intended as an exhaustive description of the invention or as alimitation on the scope of the invention. In addition, an illustratedembodiment needs not have all the aspects or advantages shown. An aspector an advantage described in conjunction with a particular embodiment isnot necessarily limited to that embodiment and can be practiced in anyother embodiments even if not so illustrated, or if not so explicitlydescribed.

Throughout this disclosure, the words “stoma” and “ostomy” are used todenote a surgically created opening bypassing the intestines or urinarytract system of a person. The words are used interchangeably, and nodifferentiated meaning is intended. The same applies for any words orphrases derived from these, e.g. “stomal”, “ostomies” etc. Also, thesolid and liquid wastes emanating from the stoma may be referred to asboth stomal “output,” “waste(s),” and “fluids” interchangeably. Asubject having undergone ostomy surgery may be referred to as “ostomist”or “ostomate”—moreover, also as “patient” or “user”. However, in somecases “user” may also relate or refer to a health care professional(HCP), such as a surgeon or an ostomy care nurse or others. In thosecases, it will either be explicitly stated, or be implicit from thecontext that the “user” is not the “patient” him- or herself.

In the following, whenever referring to proximal side or surface of alayer, an element, a device or part of a device, the referral is to theskin-facing side or surface, when a user wears the ostomy appliance.Likewise, whenever referring to the distal side or surface of a layer,an element, a device or part of a device, the referral is to the side orsurface facing away from the skin, when a user wears the ostomyappliance. In other words, the proximal side or surface is the side orsurface closest to the user, when the ostomy appliance is fitted on auser and the distal side is the opposite side or surface—the side orsurface furthest away from the user in use.

The axial direction is defined as the direction of the stoma, when auser wears the ostomy appliance. Thus, the axial direction is generallyperpendicular to the skin or abdominal surface of the user.

The radial direction is defined as perpendicular to the axial direction.In some sentences, the words “inner” and “outer” may be used. Thesequalifiers should generally be perceived with respect to the radialdirection, such that a reference to an “outer” element means that theelement is farther away from a centre portion of the ostomy appliancethan an element referenced as “inner”. In addition, “innermost” shouldbe interpreted as the portion of a component forming a centre of thecomponent and/or being adjacent to the centre of the component. Inanalogy, “outermost” should be interpreted as a portion of a componentforming an outer edge or outer contour of a component and/or beingadjacent to that outer edge or outer contour.

The use of the word “substantially” as a qualifier to certain featuresor effects in this disclosure is intended to simply mean that anydeviations are within tolerances that would normally be expected by theskilled person in the relevant field.

The use of the word “generally” as a qualifier to certain features oreffects in this disclosure is intended to simply mean—for a structuralfeature: that a majority or major portion of such feature exhibits thecharacteristic in question, and—for a functional feature or an effect:that a majority of outcomes involving the characteristic provide theeffect, but that exceptionally outcomes do no provide the effect.

The present disclosure relates to an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices. Further,methods related to the ostomy system and devices thereof are disclosed.An accessory device (also referred to as an external device) may be amobile phone or other handheld device. An accessory device may be apersonal electronic device, e.g. a wearable, such as a watch or otherwrist-worn electronic device. An accessory device may be a dockingstation. The docking station may be configured to electrically and/ormechanically couple the monitor device to the docking station. Thedocking station may be configured for charging the monitor device and/orconfigured for transferring data between the monitor device and thedocking station. The ostomy system may comprise a server device. Theserver device may be operated and/or controlled by the ostomy appliancemanufacturer and/or a service centre.

The present disclosure provides an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices whicheither alone or together facilitate reliable determination of thenature, severity and rapidness of moisture propagation in the adhesivematerial provided for attaching the base plate to the skin surface of auser. Depending on the nature of the pattern of moisture propagation inthe adhesive, the ostomy system and devices thereof enable providinginformation to the user about the type of failure, and in turn enableproviding an indication to the user of the severity and thus theremaining time frame for replacing the ostomy appliance withoutexperiencing severe leakage and/or skin damage.

The ostomy appliance comprises a base plate and an ostomy pouch (alsoreferred to as an ostomy bag). The ostomy appliance may be a colostomyappliance, an ileostomy appliance or a urostomy appliance. The ostomyappliance may be a two-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be releasably coupled e.g. with a mechanical and/oran adhesive coupling, e.g. to allow that a plurality of ostomy pouchescan be utilized (exchanged) with one base plate. Further, a two-partostomy appliance may facilitate correct application of the base plate toskin, e.g. to an improved user sight of the stomal region. The ostomyappliance may be a one-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be fixedly attached to each other. The base plateis configured for coupling to a user's stoma and/or skin surrounding thestoma, such as a peristomal skin area.

The base plate comprises a first adhesive layer, also denoted centeradhesive layer. During use, the first adhesive layer adheres to theuser's skin (peristomal area) and/or to additional seals, such assealing paste, sealing tape and/or sealing ring. Thus, the firstadhesive layer may be configured for attachment of the base plate to theskin surface of a user. The first adhesive layer may have a stomalopening with a center point.

The first adhesive layer may be made of a first composition. The firstcomposition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The first composition may comprise one or morehydrocoloids.

The first composition may be a pressure sensitive adhesive compositionsuitable for medical purposes comprising a rubbery elastomeric base andone or more water soluble or water swellable hydrocolloids. The firstcomposition may comprise one or more polybutenes, one or more styrenecopolymers, one or more hydrocolloids, or any combination thereof. Thecombination of the adhesive properties of the polybutenes and theabsorbing properties of the hydrocolloids renders the first compositionsuitable for use in ostomy appliances. The styrene copolymer may forexample be a styrene-butadiene-styrene block copolymer or astyrene-isoprene-styrene block copolymer. Preferably, one or morestyrene-isoprene-styrene (SIS) block type copolymers are employed. Theamount of styrene block-copolymer may be from 5% to 20% of the totaladhesive composition. The butene component is suitably a conjugatedbutadiene polymer selected from polybutadiene, polyisoprene. Thepolybutenes are preferably present in an amount of from 35-50% of thetotal adhesive composition. Preferably, the polybutene ispolyisobutylene (PIB). Suitable hydrocolloids for incorporation in thefirst composition are selected from naturally occurring hydrocolloids,semisynthetic hydrocolloids and synthetic hydrocolloids. The firstcomposition may comprise 20-60% hydrocolloids. A preferred hydrocolloidis carboxymethyl cellulose (CMC). The first composition may optionallycontain other components, such as fillers, tackifiers, plasticizers, andother additives.

The first adhesive layer may have a plurality of sensor point openings.A sensor point opening of the first adhesive layer is optionallyconfigured to overlap a part of an electrode, e.g. to form a sensorpoint.

The sensor point openings of the first adhesive layer may compriseprimary sensor point openings. The primary sensor point openings maycomprise one or more primary first sensor point openings and one or moreprimary second sensor point openings, the primary first sensor pointopenings configured to overlap parts of an electrode and the primarysecond sensor point openings configured to overlap parts of anotherelectrode different from the electrode at least partly overlapped by theprimary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisesecondary sensor point openings. The secondary sensor point openings maycomprise one or more secondary first sensor point openings and one ormore secondary second sensor point openings, the secondary first sensorpoint openings configured to overlap parts of an electrode and thesecondary second sensor point openings configured to overlap parts ofanother electrode different from the electrode at least partlyoverlapped by the secondary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisetertiary sensor point openings. The tertiary sensor point openings maycomprise one or more tertiary first sensor point openings and one ormore tertiary second sensor point openings, the tertiary first sensorpoint openings configured to overlap parts of an electrode and thetertiary second sensor point openings configured to overlap parts ofanother electrode different from the electrode at least partlyoverlapped by the tertiary first sensor point openings.

The first adhesive layer may have a substantially uniform thickness. Thefirst adhesive layer may have a thickness in the range from 0.1 mm to1.5 mm, e.g. in the range from 0.2 mm to 1.2 mm, such as 0.8 mm or 1.0mm.

The first adhesive layer may have a primary thickness in a primary partof the first adhesive layer, e.g. in a primary region within a primaryradial distance or in a primary radial distance range from the centerpoint of the stomal opening. The primary thickness may be in the rangefrom 0.2 mm to 1.5 mm. such as about 1.0 mm. The primary radial distancemay be in the range from 20 mm to 50 mm, such as in the range from 25 mmto 35 mm, e.g. 30 mm.

The first adhesive layer may have a secondary thickness in a secondarypart of the first adhesive layer, e.g. in a secondary region outside asecondary radial distance or in a secondary radial distance range fromthe center point of the stomal opening. The secondary thickness may bein the range from 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondaryradial distance may be in the range from 20 mm to 50 mm, such as in therange from 25 mm to 35 mm, e.g. 30 mm.

The base plate may comprise a second layer. The second layer may be anadhesive layer, also denoted rim adhesive layer. The second layer mayhave a second radial extension that is larger than a first radialextension of the first adhesive layer at least in a first angular rangeof the base plate. Accordingly, a part of a proximal surface of thesecond layer may be configured for attachment to the skin surface of auser. The part of a proximal surface of the second layer configured forattachment to the skin surface of a user is also denoted the skinattachment surface of the second adhesive layer. The second layer mayhave a stomal opening with a center point.

The second adhesive layer may be made of a second composition. Thesecond composition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The second composition may comprise one ormore hydrocoloids.

The second composition may be a pressure sensitive adhesive compositionsuitable for medical purposes comprising a rubbery elastomeric base andone or more water soluble or water swellable hydrocolloids. The secondcomposition may comprise one or more polybutenes, one or more styrenecopolymers, one or more hydrocolloids, or any combination thereof. Thecombination of the adhesive properties of the polybutenes and theabsorbing properties of the hydrocolloids renders the second compositionsuitable for use in ostomy appliances. The styrene copolymer may forexample be a styrene-butadiene-styrene block copolymer or astyrene-isoprene-styrene block copolymer. Preferably, one or morestyrene-isoprene-styrene (SIS) block type copolymers are employed. Theamount of styrene block-copolymer may be from 5% to 20% of the totaladhesive composition. The butene component is suitably a conjugatedbutadiene polymer selected from polybutadiene, polyisoprene. Thepolybutenes are preferably present in an amount of from 35-50% of thetotal adhesive composition. Preferably, the polybutene ispolyisobutylene (PIB). Suitable hydrocolloids for incorporation in thesecond composition are selected from naturally occurring hydrocolloids,semisynthetic hydrocolloids and synthetic hydrocolloids. The secondcomposition may comprise 20-60% hydrocolloids. A preferred hydrocolloidis carboxymethyl cellulose (CMC). The second composition may optionallycontain other components, such as fillers, tackifiers, plasticizers, andother additives.

Different ratio of contents may change properties of the first and/orsecond adhesive layers. The second adhesive layer and the first adhesivelayer may have different properties. The second adhesive layer (secondcomposition) and the first adhesive layer (first composition) may havedifferent ratios of polyisobutenes, styrene-isoprene-styrene, and/orhydrocoloids. For example, the second adhesive layer may provide astronger attachment to the skin compared to attachment to the skinprovided by the first adhesive layer. Alternatively or additionally, thesecond adhesive layer may be thinner than the first adhesive layer.Alternatively or additionally, the second adhesive layer may be lesswater and/or sweat absorbing than the first adhesive layer.Alternatively or additionally, the second adhesive layer may be lessmouldable than the first adhesive layer. The second adhesive layer mayprovide a second barrier against leakage.

The second layer may have a substantially uniform thickness. The secondlayer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. inthe range from 0.2 mm to 1.0 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm.

The base plate comprises one or more electrodes, such as a plurality ofelectrodes, such as two, three, four, five, six, seven or moreelectrodes. The electrodes, e.g. some or all the electrodes, may bearranged between the first adhesive layer and the second adhesive layer.The electrodes may be arranged in an electrode assembly, e.g. anelectrode layer. An electrode comprises a connection part for connectingthe electrodes to other components and/or interface terminals. Anelectrode may comprise one or more conductor parts and/or one or moresensing parts. The electrode assembly may be arranged between the firstadhesive layer and the second adhesive layer. The base plate, e.g. theelectrode assembly, may comprise a first electrode, a second electrodeand optionally a third electrode. The base plate, e.g. the electrodeassembly, may comprise a fourth electrode and/or a fifth electrode. Thebase plate, e.g. the electrode assembly, optionally comprises a sixthelectrode. The base plate, e.g. the electrode assembly, may comprise aground electrode. The ground electrode may comprise a first electrodepart. The first electrode part of the ground electrode may form a groundfor the first electrode. The ground electrode may comprise a secondelectrode part. The second electrode part of the ground electrode mayform a ground for the second electrode. The ground electrode maycomprise a third electrode part. The third electrode part of the groundelectrode may form a ground for the third electrode. The groundelectrode may comprise a fourth electrode part. The fourth electrodepart of the ground electrode may form a ground for the fourth electrodeand/or the fifth electrode.

The ground electrode or electrode parts of the ground electrode may beconfigured as or form a (common) reference electrode for some or all ofthe other electrodes of the electrode assembly. The ground electrode mayalso be denoted reference electrode.

The electrodes are electrically conductive and may comprise one or moreof metallic (e.g. silver, copper, gold, titanium, aluminium, stainlesssteel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), andcarbonaceous (e.g. carbon black, carbon nanotube, carbon fibre,graphene, graphite) materials.

The ground electrode may comprise a first electrode part and a secondelectrode part, the first electrode part forming the ground for thefirst electrode and the second electrode part forming the ground for thesecond electrode. The first electrode part may form a closed loop.

The electrodes are electrically conductive and may comprise one or moreof metallic (e.g. silver, copper, gold, titanium, aluminium, stainlesssteel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), andcarbonaceous (e.g. carbon black, carbon nanotube, carbon fibre,graphene, graphite) materials.

Two electrodes of the electrode assembly may form a sensor. The firstelectrode and the ground electrode (e.g. first electrode part of theground electrode) may form a first sensor or first electrode pair. Thesecond electrode and the ground electrode (e.g. second electrode part ofthe ground electrode) may form a second sensor or second electrode pair.The third electrode and the ground electrode (e.g. third electrode partof the ground electrode) may form a third sensor or third electrodepair. The fourth electrode and the ground electrode (e.g. fourthelectrode part of the ground electrode) may form a fourth sensor orfourth electrode pair. The fifth electrode and the ground electrode(e.g. fifth electrode part of the ground electrode) may form a fifthsensor or fifth electrode pair. The fourth electrode and the fifthelectrode may form a sixth sensor or sixth electrode pair.

An electrode may comprise a sensing part or a plurality of sensingparts, i.e. the part(s) of an electrode that are used for sensing. Thefirst electrode may comprise a first sensing part. The first sensingpart may contact the first adhesive layer and is optionally arranged atleast partly annularly around the stomal opening. The first electrodemay comprise a first conductor part insulated from the first adhesivelayer, e.g. by a masking element arranged between the first conductorpart and the first adhesive layer. The first sensing part may extend atleast 270 degrees around the stomal opening, such as at least 300degrees around the stomal opening. The first sensing part of the firstelectrode may be arranged at a first ground distance from the firstelectrode part of the ground electrode. The first ground distance may beless than 5 mm, such as less than 3 mm, e.g. about 1.0 mm.

The second electrode may comprise a second sensing part. The secondsensing part may contact the first adhesive layer. The second sensingpart may be arranged at least partly annularly around the stomalopening. The second sensing part may extend at least 270 degrees aroundthe stomal opening, such as at least 300 degrees around the stomalopening. The second sensing part of the second electrode may be arrangedat a second ground distance from the second electrode part of the groundelectrode. The second ground distance may be less than 5 mm, such asless than 3 mm, e.g. about 1.0 mm.

The first sensing part may be arranged at a first radial distance fromthe center point and the second sensing part may be arranged at a secondradial distance from the center point. The second radial distance may belarger than the first radial distance. The second electrode may comprisea second conductor part insulated from the first adhesive layer, e.g. bya masking element arranged between the second conductor part and thefirst adhesive layer. The first radial distance may vary as a functionof an angular position with respect to a zero direction from the centerpoint. The second radial distance may vary as a function of an angularposition with respect to a zero direction from the center point. Thezero direction may be defined as the vertical upward direction when thebase plate is in its intended wearing position on an upstanding user.

The first radial distance may be in the range from 5 mm to 40 mm, suchas in the range from 10 mm to 25 mm, e.g. about 14 mm. The second radialdistance may be in the range from 10 mm to 50 mm, such as in the rangefrom 10 mm to 25 mm, e.g. about 18 mm.

The base plate may comprise a third electrode comprising a thirdconnection part. The ground electrode may form a ground for the thirdelectrode. The ground electrode may comprise a third electrode part, thethird electrode part forming the ground for the third electrode. Thethird electrode may comprise a third conductor part insulated from thefirst adhesive layer, e.g. by a masking element arranged between thethird conductor part and the first adhesive layer. The third electrodemay comprise a third sensing part, the third sensing part contacting thefirst adhesive layer. The third sensing part may be arranged at leastpartly annularly around the stomal opening. The third sensing part maybe arranged at a third radial distance from the center point. The thirdradial distance may be larger than the first radial distance and/orlarger than the second radial distance. The third radial distance may bein the range from 15 mm to 50 mm. such as in the range from 20 mm to 30mm, e.g. about 26 mm. The third sensing part may extend at least 270degrees around the stomal opening, such as at least 300 degrees aroundthe stomal opening. The third sensing part of the third electrode may bearranged at a third ground distance from the third electrode part of theground electrode. The third ground distance may be less than 5 mm, suchas less than 3 mm, e.g. about 1.0 mm. A base plate with a groundelectrode, a first electrode, a second electrode, and a third electrodeallows for a failsafe base plate in case e.g. the first electrode is cutor otherwise destroyed during preparation of the base plate.

The base plate may comprise a fourth electrode comprising a fourthconnection part. The ground electrode may form a ground for the fourthelectrode. The ground electrode may comprise a fourth electrode part,the fourth electrode part forming the ground for the fourth electrode.The fourth electrode may comprise one or a plurality of fourth sensingparts, such as at least five fourth sensing parts. The fourth sensingparts may be distributed around the stomal opening or a center pointthereof. The fourth sensing parts may be arranged at respective fourthradial distances from the center point. The fourth radial distance(s)may be larger than the third radial distance. The fourth radialdistance(s) may be in the range from 25 mm to 50 mm, such as about 30 mm

The base plate may comprise a fifth electrode comprising a fifthconnection part. The ground electrode may form a ground for the fifthelectrode. The ground electrode may comprise a fifth electrode part, thefifth electrode part forming the ground for the fifth electrode. Thefifth electrode may comprise one or a plurality of fifth sensing parts,such as at least five fifth sensing parts. The fifth sensing parts maybe distributed around the stomal opening or a center point thereof. Thefifth sensing parts may be arranged at respective fifth radial distancesfrom the center point. The fifth radial distance may be larger than thethird radial distance. The fifth radial distance may be equal to orlarger than the fourth radial distance. The fifth radial distance(s) maybe in the range from 25 mm to 50 mm, such as about 30 mm.

The first electrode may form an open loop. The second electrode may forman open loop and/or the third electrode may form an open loop. Thefourth electrode may form an open loop. The fifth electrode may form anopen loop. Open loop electrode(s) enables electrode arrangement in fewor a single electrode layer.

The base plate may comprise a second adhesive layer, wherein theplurality of electrodes is arranged between the first adhesive layer andthe second adhesive layer.

The electrode assembly may comprise a support layer, also denoted asupport film. One or more electrodes may be formed, e.g. printed, on theproximal side of the support layer. One or more electrodes may beformed, e.g. printed, on the distal side of the support layer. Thus, oneor more electrodes may be arranged between the support layer and thefirst adhesive layer. The electrode assembly may have a stomal openingwith a center point.

The support layer may comprise polymeric (e.g. polyurethane, PTFE, PVDF)and/or ceramic (e.g. alumina, silica) materials. In one or moreexemplary base plates, the support layer is made of thermoplasticpolyurethane (TPU). The support layer material may be made of orcomprise one or more of polyester, a thermoplastic elastomer (TPE),polyamide, polyimide, Ethylene-vinyl acetate (EVA), polyurea, andsilicones.

Exemplary thermoplastic elastomers of the support layer are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The electrode assembly/base plate may comprise a masking elementconfigured to insulate at least parts of the electrodes from the firstadhesive layer of the base plate. The masking element may comprise oneor more, such as a plurality of, sensor point openings. The sensor pointopenings may comprise primary sensor point openings and/or secondarysensor point openings. The sensor point openings may comprise tertiarysensor point opening(s). The sensor point openings may comprisequaternary sensor point opening(s) A sensor point opening of the maskingelement overlaps at least one electrode of the electrode assembly whenseen in the axial direction, e.g. to form a sensor point. For example, aprimary sensor point opening may overlap a part of the ground electrodeand/or a part of the fourth electrode. A secondary sensor point openingmay overlap a part of the fourth electrode and/or a part of the fifthelectrode. A tertiary sensor point opening may overlap a part of thefifth electrode and/or a part of the ground electrode.

The masking element may comprise one or more, such as a plurality of,terminal openings. A terminal opening may overlap with one or moreconnection parts of electrodes. In one or more exemplary base plates,each terminal opening overlaps with a single connection part of anelectrode. The masking element may comprise polymeric (e.g.polyurethane, PTFE, PVDF) and/or ceramic (e.g. alumina, silica)materials. In one or more exemplary base plates, the masking element ismade of or comprises thermoplastic polyurethane (TPU). In one or moreexemplary base plates, the masking element is made of or comprisespolyester. The masking element material may be made of or comprise oneor more of polyester, a thermoplastic elastomer (TPE), polyamide,polyimide, Ethylene-vinyl acetate (EVA), polyurea, and silicones.

Exemplary thermoplastic elastomers of the masking element are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The base plate may comprise a first intermediate element. The firstintermediate element may be arranged between the electrodes/electrodelayer and the first adhesive layer and/or between the second layer andthe first adhesive layer. The first intermediate layer may be made of aninsulating material.

The base plate may comprise a release liner. The release liner is aprotective layer that protects adhesive layer(s) during transport andstorage and is peeled off by the user prior to applying the base plateon the skin. The release liner may have a stomal opening with a centerpoint.

The base plate may comprise a top layer. The top layer is a protectivelayer protecting the adhesive layer(s) from external strains and stresswhen the user wears the ostomy appliance. The electrodes, e.g. some orall the electrodes, may be arranged between the first adhesive layer andthe top layer. The top layer may have a stomal opening with a centerpoint. The top layer may have a thickness in the range from 0.01 mm to1.0 mm, e.g. in the range from 0.02 mm to 0.2 mm, such as 0.04 mm. Thetop layer may have a stomal opening with a center point.

The base plate comprises a monitor interface. The monitor interface maybe configured for electrically and/or mechanically connecting the ostomyappliance (base plate) to the monitor device. The monitor interface maybe configured for wirelessly connecting the ostomy appliance (baseplate) to the monitor device. Thus, the monitor interface of the baseplate is configured to electrically and/or mechanically couple theostomy appliance and the monitor device.

The monitor interface of the base plate may comprise, e.g. as part of afirst connector of the monitor interface, a coupling part for forming amechanical connection, such as a releasable coupling between the monitordevice and the base plate. The coupling part may be configured to engagewith a coupling part of the monitor device for releasably coupling themonitor device to the base plate.

The monitor interface of the base plate may comprise, e.g. as part of afirst connector of the monitor interface, a plurality of terminals, suchas two, three, four, five, six, seven or more terminals, for formingelectrical connections with respective terminals of the monitor device.The monitor interface may comprise a ground terminal element forming aground terminal. The monitor interface may comprise a first terminalelement forming a first terminal, a second terminal element forming asecond terminal and optionally a third terminal element forming a thirdterminal. The monitor interface may comprise a fourth terminal elementforming a fourth terminal and/or a fifth terminal element forming afifth terminal. The monitor interface optionally comprises a sixthterminal element forming a sixth terminal. The terminal elements of themonitor interface may contact respective electrodes of the baseplate/electrode assembly. The first intermediate element may be arrangedbetween the terminal elements and the first adhesive layer. The firstintermediate element may cover or overlap terminal element(s) of thebase plate when seen in the axial direction. Thus, the first adhesivelayer may be protected or experience more evenly distributed mechanicalstress from the terminal elements of the base plate, in turn reducingthe risk of terminal elements penetrating or otherwise damaging thefirst adhesive layer. The first intermediate element may protect ormechanically and/or electrically shield the first adhesive layer fromthe terminal elements of the base plate.

A terminal element, such as the ground terminal element, the firstterminal element, the second terminal element, the third terminalelement, the fourth terminal element, the fifth terminal element and/orthe sixth terminal element, may comprise a distal end and a proximalend. A terminal element, such as the ground terminal element, the firstterminal element, the second terminal element, the third terminalelement, the fourth terminal element, the fifth terminal element and/orthe sixth terminal element, may comprise a distal part, a centre part,and/or a proximal part. The distal part may be between the distal endand the centre part. The proximal part may be between the proximal endand the centre part. The proximal end/proximal part of a terminalelement may contact a connection part of an electrode. A terminalelement, such as the ground terminal element, the first terminalelement, the second terminal element, the third terminal element, thefourth terminal element, the fifth terminal element and/or the sixthterminal element, may be gold plated copper.

The base plate may comprise a coupling ring or other coupling member forcoupling an ostomy pouch to the base plate (two-part ostomy appliance).The center point may be defined as a center of the coupling ring.

The base plate has a stomal opening with a center point. The size and/orshape of the stomal opening is typically adjusted by the user or nursebefore application of the ostomy appliance to accommodate the user'sstoma. In one or more exemplary base plates, the user forms the stomalopening during preparation of the base plate for application.

A monitor device for an ostomy system comprising an ostomy appliancewith a base plate is disclosed, the monitor device comprising aprocessor configured to apply a processing scheme; memory; a firstinterface connected to the processor and the memory, the first interfaceconfigured for collecting ostomy data from the base plate coupled to thefirst interface, the ostomy data comprising one or more, such as all, offirst ostomy data from a first electrode pair of the base plate, secondostomy data from a second electrode pair of the base plate, andoptionally third ostomy data from a third electrode pair of the baseplate; and a second interface connected to the processor. To apply aprocessing scheme comprises obtain first parameter data based on thefirst ostomy data; obtain second parameter data based on the secondostomy data; and optionally obtain third parameter data based on thethird ostomy data. To apply a processing scheme comprises determine anoperating state of the base plate of the ostomy appliance. To determinethe operating state of the base plate may be based on one or more, suchas all, of the first parameter data, the second parameter data, thethird parameter data, and fourth parameter data. The operating state maybe indicative of a degree of radial erosion and/or radial swelling ofthe base plate, such as of the first adhesive layer, and/or an acuteleakage risk for the ostomy appliance. The monitor device may beconfigured to transmit a monitor signal comprising monitor dataindicative of the determined operating state of the base plate via thesecond interface. The monitor device may be configured to, in accordancewith a determination that the operating state is a first operatingstate, transmit a first monitor signal comprising monitor dataindicative of the first operating state of the base plate via the secondinterface. The monitor device may be configured to, in accordance with adetermination that the operating state is a second operating state,transmit a second monitor signal comprising monitor data indicative ofthe second operating state of the base plate via the second interface.

An operating state in the present disclosure is indicative of thedynamic internal state of the ostomy appliance (e.g. of the base plateof the ostomy appliance currently being worn by the user) optionallyrelated to adhesive performance of the ostomy appliance. Adhesiveperformance of the ostomy appliance may be related to an internalcondition of the ostomy appliance (e.g. of the base plate of the ostomyappliance), such as an internal condition of an adhesive layer of theostomy appliance. The adhesive performance, and thereby the operatingstate may be affected by several factors, such as humidity, temperature,misplacement of the ostomy appliance on the stoma, and/or malfunction ofthe ostomy appliance. The one or more factors alone or in combinationimpact the adhesive performance of the ostomy appliance. The operatingstate may be varying in time. The operating state may be indicative of adegree of erosion of the base plate.

Adhesive performance may be indicative of wear property, e.g. wear timeand/or wear comfort. The operating state may comprise at least one of: awear time, a quality of adhesion, and a moisture pattern representation.Wear time may comprise average wear time, nominal wear time, minimalwear time, maximal wear time, median wear time, and/or any of otherstatistical metric derivable from wear time. Wear time may compriseremaining wear time and/or current wear time and/or elapsed wear time. Aquality of adhesion may comprise a metric indicative of erosion of alayer of the base plate, such as of the first adhesive layer. A moisturepattern representation may comprise one or more metrics or parametersrepresentative or indicative of a moisture pattern (e.g. a moisturepattern type), e.g. a moisture pattern of the first adhesive layer.

An operating state may be configured to indicate whether the ostomyappliance is properly operational based on its adhesive performance(e.g. wear property, e.g. wear time and/or wear comfort). For example,the operating state may be indicative of the severity and/or imminenceof a leakage (e.g. low, medium, high or acute).

In one or more exemplary monitor devices, the processor is configured toapply a processing scheme, the first interface is connected to theprocessor and the memory, and the first interface is configured forcollecting ostomy data from the base plate coupled to the firstinterface. The ostomy data may comprise one or more, such as all, offirst ostomy data from a first electrode pair of the base plate, secondostomy data from a second electrode pair of the base plate, and thirdostomy data from a third electrode pair of the base plate. A secondinterface is connected to the processor. To apply a processing schememay comprise one or more of obtain first parameter data based on thefirst ostomy data; obtain second parameter data based on the secondostomy data; and obtain third parameter data based on the third ostomydata. To apply a processing scheme may comprise determine an operatingstate of the base plate of the ostomy appliance based on one or more,such as all, of the first parameter data, the second parameter data andthe third parameter data. The operating state may be indicative of adegree of radial erosion of the base plate, such as of the firstadhesive layer, and/or an acute leakage risk for the ostomy appliance.The monitor device is configured to, in accordance with a determinationthat the operating state is a first operating state, transmit a firstmonitor signal comprising monitor data indicative of the first operatingstate of the base plate via the second interface; and/or in accordancewith a determination that the operating state is a second operatingstate, transmit a second monitor signal comprising monitor dataindicative of the second operating state of the base plate via thesecond interface.

In one or more exemplary monitor devices, the first operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate has experienced a first degree of radialerosion, e.g. the first adhesive layer is eroded to a first radialdistance of the first electrode pair but not to a second radial distanceof the second electrode pair.

In one or more exemplary monitor devices, the second operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate has experienced a second degree of radialerosion, e.g. the first adhesive layer is eroded to the second radialdistance of the second electrode pair but not to a third radial distanceof the third electrode pair.

To obtain first parameter data based on the first ostomy data maycomprise determining one or more first parameters based on the firstostomy data. To obtain second parameter data based on the second ostomydata may comprise determining one or more second parameters based on thesecond ostomy data. To obtain third parameter data based on the thirdostomy data may comprise determining one or more third parameters basedon the third ostomy data. In one or more exemplary monitor devices,determination of an operating state may be based on one or more firstparameters, such as first primary parameter and/or first secondaryparameter of first parameter data. In one or more exemplary monitordevices, determination of an operating state may be based on one or moresecond parameters, such as second primary parameter and/or secondsecondary parameter of the second parameter data. In one or moreexemplary monitor devices, determination of an operating state may bebased on one or more third parameters, such as third primary parameterand/or third secondary parameter of the third parameter data. In one ormore exemplary monitor devices, determination of an operating state maybe based on one or more fourth parameters, such as fourth primaryparameter and/or fourth secondary parameter of the fourth parameterdata.

The monitor device comprises a monitor device housing optionally made ofa plastic material. The monitor device housing may be an elongatehousing having a first end and a second end. The monitor device housingmay have a length or maximum extension along a longitudinal axis in therange from 1 cm to 15 cm. The monitor device housing may have a width ormaximum extension perpendicular to the longitudinal axis in the rangefrom 0.5 cm to 3 cm. The monitor device housing may be curve-shaped.

The monitor device comprises a first interface connected to theprocessor. The first interface may be configured as an applianceinterface for electrically and/or mechanically connecting the monitordevice to the ostomy appliance. Thus, the appliance interface isconfigured to electrically and/or mechanically couple the monitor deviceand the ostomy appliance. The first interface may be configured as anaccessory device interface for electrically and/or mechanicallyconnecting the monitor device to an accessory device, such as a dockingstation. The first interface may be configured for coupling to a dockingstation of the ostomy system, e.g. for charging the monitor deviceand/or for data transfer between the monitor device and the dockingstation.

The first interface of the monitor device may comprise a plurality ofterminals, such as two, three, four, five, six, seven or more terminals,for forming electrical connections with respective terminals and/orelectrodes of the ostomy appliance. One or more terminals of the firstinterface may be configured for forming electrical connections with anaccessory device, e.g. with respective terminals of a docking station.The first interface may comprise a ground terminal. The first interfacemay comprise a first terminal, a second terminal and optionally a thirdterminal. The first interface may comprise a fourth terminal and/or afifth terminal. The first interface optionally comprises a sixthterminal. In one or more exemplary monitor devices, the first interfacehas M terminals, wherein M is an integer in the range from 4 to 8.

The first interface of the monitor device may comprise a coupling partfor forming a mechanical connection, such as a releasable couplingbetween the monitor device and the base plate. The coupling part and theterminals of the first interface form (at least part of) a firstconnector of the monitor device.

The monitor device comprises a power unit for powering the monitordevice. The power unit may comprise a battery. The power unit maycomprise charging circuitry connected to the battery and terminals ofthe first interface for charging the battery via the first interface,e.g. the first connector. The first interface may comprise separatecharging terminal(s) for charging the battery.

The monitor device may comprise a sensor unit with one or more sensors.The sensor unit is connected to the processor for feeding sensor data tothe processor. The sensor unit may comprise an accelerometer for sensingacceleration and provision of acceleration data to the processor. Thesensor unit may comprise a temperature sensor for provision oftemperature data to the processor.

The monitor device comprises a second interface connected to theprocessor. The second interface may be configured as an accessoryinterface for connecting, e.g. wirelessly connecting, the monitor deviceto one or more accessory devices. The second interface may comprise anantenna and a wireless transceiver, e.g. configured for wirelesscommunication at frequencies in the range from 2.4 to 2.5 GHz. Thewireless transceiver may be a Bluetooth transceiver, i.e. the wirelesstransceiver may be configured for wireless communication according toBluetooth protocol, e.g. Bluetooth Low Energy, Bluetooth 4.0, Bluetooth5. The second interface optionally comprises a loudspeaker and/or ahaptic feedback element for provision of an audio signal and/or hapticfeedback to the user, respectively. The processor may be configured totransmit a monitor signal, such as third monitor signal and/or fourthmonitor signal via the loudspeaker. The processor may be configured totransmit a monitor signal, such as one or more, e.g. all, of firstmonitor signal, second monitor signal, third monitor signal, fourthmonitor signal and default monitor signal, as a wireless monitor signalvia the antenna and the wireless transceiver.

In one or more exemplary ostomy systems, the monitor device forms anintegrated part of the ostomy appliance, e.g. the monitor device mayform an integrated part of a base plate of the ostomy appliance.

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of resistance between the firstelectrode pair, the second electrode pair, and the third electrode pair,respectively. The first parameter data, the second parameter data, andthe third parameter data may be indicative of voltage between the firstelectrode pair, the second electrode pair, and the third electrode pair,respectively (and thus indicative of resistance). The first parameterdata, the second parameter data, and the third parameter data may beindicative of current between the first electrode pair, the secondelectrode pair, and the third electrode pair, respectively (and thusindicative of resistance).

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of resistance between the firstelectrode pair, the second electrode pair, and the third electrode pair,respectively.

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of a rate of change in resistancebetween the first electrode pair, the second electrode pair, and thethird electrode pair, respectively. In one or more exemplary monitordevices, the first parameter data, the second parameter data, and thethird parameter data may be indicative of a rate of change in voltagebetween the first electrode pair, the second electrode pair, and thethird electrode pair, respectively. In one or more exemplary monitordevices, the first parameter data, the second parameter data, and thethird parameter data may be indicative of a rate of change in currentbetween the first electrode pair, the second electrode pair, and thethird electrode pair, respectively.

To determine an operating state of the base plate of the ostomyappliance may comprise to determine an operating state from a set ofoperating states. In other words, to determine an operating state maycomprise selecting an operating state from a set of predefined operatingstates. The set of predefined operating states may comprise a number ofoperating states, such as at least two operating states, at least threeoperating states, at least four operating states, at least fiveoperating states. The number of operating states may be in the rangefrom four to twenty. In one or more exemplary monitor devices, thenumber of operating states in the set of predefined operating states. islarger than ten, such as larger than 20 or even larger than 50.

In one or more exemplary monitor devices, the processor is configured todetermine an operating state of the base plate if a change criterion isfulfilled. The change criterion may be based on the first parameterdata, the second parameter data and/or the third parameter data. Thechange criterion may be fulfilled if parameter data changes, e.g. if achange in parameter data is larger than a change threshold. Thus,operating state determination may be conditional or dependent on achange in the parameter data, in turn leading to an optimum use of poweror battery resources in the monitor device, since operating statedetermination is only performed when there may be a change in theoperating state as a consequence of the change in parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a first criteria set based on thefirst parameter data and/or the second parameter data, wherein theoperating state is determined to be the first operating state if thefirst criteria set is satisfied. The first criteria set may comprise oneor more first criteria based on one or more of first parameter data,second parameter data and third parameter data. The first criteria setmay comprise a first primary criterion based on the first parameterdata. The first criteria set may comprise a first secondary criterionbased on the second parameter data. The first criteria set may comprisea first tertiary criterion based on the third parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate may be based on a first threshold set comprisingone or a plurality of first threshold values. The first threshold setmay comprise one or a plurality of threshold values, e.g. to be appliedin the first criteria set. The first threshold set may comprise a firstprimary threshold value. The first threshold set may comprise a firstsecondary threshold value. The first threshold set may comprise a firsttertiary threshold value.

The first criteria set may be given by or at least may comprise:

-   -   (P_1_1<TH_1_1),    -   (P_2_1>TH_1_2), and    -   (P_3_1>TH_1_3),        wherein P_1_1 is a first primary parameter based on the first        parameter data, TH_1_1 is a first primary threshold value, P_2_1        is a second primary parameter based on the second parameter        data, TH_1_2 is a first secondary threshold value, P_3_1 is a        third primary parameter based on the third parameter data, and        TH_1_3 is a first tertiary threshold value, and wherein the        first operating state is indicative of low degree of radial        erosion on the base plate. The first threshold values (TH_1_1,        TH_1_2 and TH_1_3) may be the same or different, e.g. depending        on the electrode configuration of the base plate. The first        tertiary criterion (P_3_1<TH_1_3) may be omitted in the first        criteria set. The first operating state, e.g. indicative of low        degree of radial erosion on the base plate may be indicative of        a radial progression of moisture to the first electrode pair        (but not to the second electrode pair and not to the third        electrode pair) which corresponds to e.g. an un-alarming and/or        normal radial progression of moisture.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of resistance between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the firstthreshold values (TH_1_1, TH_1_2 and TH_1_3) may correspond to firstresistance threshold values. In one or more exemplary embodiments, thefirst primary threshold value TH_1_1 may correspond to an upperresistance threshold value. An upper resistance threshold value may beset to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms,such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. In one or more exemplaryembodiments, the first secondary threshold value TH_1_2 may correspondto the upper resistance threshold value. In one or more exemplaryembodiments, the first tertiary threshold value TH_1_3 may correspond tothe upper resistance threshold value.

The first primary parameter P_1_1 may be indicative of the resistancebetween the first electrode pair (first electrode and first electrodepart of the ground electrode) of the base plate. The first parameterdata may comprise a first secondary parameter which may be derived fromthe first primary parameter, and/or a first tertiary parameter, whichmay be derived from the first primary parameter. A first secondaryparameter P_1_2 may comprise or be a gradient derived from the firstprimary parameter. In one or more embodiments, a first primary parameterP_1_1 may be indicative of a voltage between the first electrode pair(first electrode and first electrode part of the ground electrode) ofthe base plate.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of voltage between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the firstthreshold values (TH_1_1, TH_1_2 and TH_1_3) may correspond to firstvoltage threshold values. In one or more exemplary embodiments, thefirst primary threshold value TH_1_1 may correspond to an upper voltagethreshold value. An upper voltage threshold value may be set to a valueless than 5 Volts, such as 3 Volts, such as 2.86 Volts. In one or moreexemplary embodiments, the first secondary threshold value TH_1_2 maycorrespond to the upper voltage threshold value. In one or moreexemplary embodiments, the first tertiary threshold value TH_1_3 maycorrespond to the upper voltage threshold value.

The first criteria set may comprise e.g.:

-   -   (P_4_1>TH_1_4)        wherein P_4_1 is a fourth primary parameter based on the fourth        parameter data and indicative of the resistance, voltage, or        current between the fourth electrode pair and TH_1_4 is a first        quaternary threshold value, and wherein the first operating        state is indicative of absence of fluid on the proximal side of        the first adhesive layer of the base plate of the ostomy        appliance. In one or more exemplary embodiments, the first        quaternary threshold value TH_1_4 may correspond to an upper        resistance threshold value. An upper resistance threshold value        may be set to a value which is less than 30 Mega-Ohms, such as        25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms.

In one or more exemplary embodiments, the following additional criterionmay be determined:

-   -   (P_1_1<TH_low),        wherein P_1_1 is a first primary parameter based on the first        parameter data, TH_low is a threshold value corresponding to a        lower resistance threshold value. In one or more exemplary        embodiments, a lower resistance threshold value may be set to a        value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80        kilo-Ohms, such as 79 kilo-Ohms. This is indicative of a        saturation of the first electrode pair by the moisture detected        and there are no further changes expected by the first primary        parameter. Moisture is likely to continue its progression.

In one or more exemplary embodiments, the following additional criterionmay be determined:

-   -   (P_2_1<TH_low),        wherein P_2_1 is a second primary parameter based on the second        parameter data, TH_low is a threshold value corresponding to a        lower resistance threshold value. In one or more exemplary        embodiments, a lower resistance threshold value may be set to a        value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80        kilo-Ohms, such as 79 kilo-Ohms. This is indicative of a        saturation of the second electrode pair by the moisture detected        and there are no further changes expected by the second primary        parameter. Moisture is likely to continue its progression.

In one or more exemplary embodiments, the following additional criterionmay be determined:

-   -   (P_3_1>TH_low),        P_3_1 is a third primary parameter based on the third parameter        data, and TH_low is a threshold value corresponding to a lower        resistance threshold value. In one or more exemplary        embodiments, a lower resistance threshold value may be set to a        value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80        kilo-Ohms, such as 79 kilo-Ohms. This is indicative of a        saturation of the third electrode pair by the moisture detected        and there are no further changes expected by the second primary        parameter. Moisture is likely to continue its progression.

In one or more exemplary embodiments, one or more criteria of a criteriaset, e.g. one or more first criteria of the first criteria set and/orone or more second criteria of the second criteria set, may be based ontiming information or one or more delay parameters based on theparameter data. In one or more exemplary embodiments, one or more delayparameters or time differences related to different parameter data, e.g.related to the first parameter data and the second parameter data, aredetermined.

In one or more exemplary embodiments, one or more first criteria of thefirst criteria set may be based on timing information (e.g. one or moredelay parameters of the parameter data and/or one or more times where aparameter crosses a threshold).

In one or more exemplary embodiments, the timing information maycomprise a time difference D_1_2_1 between a time T1 where P_1_1 crossesa threshold, such as TH_1_1, and a time T2 where P_2_1 crosses athreshold, such as TH_1_2. Thus, delay parameter or time differenceD_1_2_1 may be given as D_1_2_1=T2−T1.

In one or more exemplary embodiments, the timing information, e.g. usedin the first criteria set, may comprise a time difference D_2_3_1between a time T2 where P_2_1 crosses a threshold, such as TH_1_2, and atime T3 where P_3_1 crosses a threshold, such as TH_1_3. Thus, delayparameter or time difference D_2_3_1 may be given as D_2_3_1=T3−T2.

In one or more exemplary embodiments, one or more criteria sets, such asthe third criteria set and/or the second criteria set, may comprise anyof:

-   -   D_1_2_1>Z    -   D_2_3_1>Z        wherein Z is a time difference constant characterizing the        progression of moisture (e.g. 3 h, e.g. 2 h). Different time        difference constants may be employed in different criteria        sets/for different time delays.

In one or more exemplary embodiments, one or more criteria sets, such asthe second criteria set and/or the third criteria set may comprise anyof:

-   -   D_1_2_1>Z        wherein Z is a time difference constant characterizing the        progression of moisture (e.g. 3 h, e.g. 2 h).

The second primary parameter may be indicative of the resistance betweenthe second electrode pair (second electrode and second electrode part ofthe ground electrode) of the base plate. The second parameter data maycomprise a second secondary parameter, and/or a second tertiaryparameter, which may be derived from the second primary parameter. Asecond secondary parameter may be indicative of a voltage between thesecond electrode pair (second electrode and second electrode part of theground electrode) of the base plate.

The third primary parameter may be indicative of resistance between thethird electrode pair (third electrode and third electrode part of theground electrode) of the base plate. The third parameter data maycomprise a third secondary parameter, and/or a third tertiary parameter,which may be derived from the third primary parameter. A third secondaryparameter may be indicative of a voltage between the second electrodepair (second electrode and second electrode part of the groundelectrode) of the base plate.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a second criteria set based on thesecond parameter data and/or the third parameter data, wherein theoperating state is determined to be the second operating state if thesecond criteria set is satisfied. The second criteria set may be basedon the first parameter data.

The second criteria set may comprise one or more second criteria basedon one or more of first parameter data, second parameter data and thirdparameter data. The second criteria set may comprise a second primarycriterion based on the first parameter data. The second criteria set maycomprise a second secondary criterion based on the second parameterdata. The second criteria set may comprise a second tertiary criterionbased on the third parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a second threshold set comprisingone or a plurality of second threshold values. The second threshold setmay comprise one or a plurality of threshold values, e.g. to be appliedin the second criteria set. The second threshold set may comprise asecond primary threshold value. The second threshold set may comprise asecond secondary threshold value. The second threshold set may comprisea second tertiary threshold value.

The second criteria set may be given by or at least may comprise:

-   -   (P_1_1<TH_2_1),    -   (P_2_1<TH_2_2), and    -   (P_3_1>TH_2_3)        wherein P_1_1 is a first primary parameter based on the first        parameter data and indicative of the resistance between the        first electrode pair, TH_2_1 is a second primary threshold        value, P_2_1 is a second primary parameter based on the second        parameter data and indicative of the resistance between the        second electrode pair, TH_2_2 is a second secondary threshold        value, P_3_1 is a third primary parameter based on the third        parameter data and indicative of the resistance between the        third electrode pair, TH_2_3 is a second tertiary threshold        value, and wherein the second operating state is indicative of        medium degree of radial erosion on the base plate. The second        threshold values (TH_2_1, TH_2_2 and TH_2_3) may be the same or        different, e.g. depending on the electrode configuration of the        base plate. The second primary criterion (P_1_1<TH_2_1) and/or        the second tertiary criterion (P_3_1>TH_2_3) may be omitted in        the second criteria set.

The second operating state indicative of medium degree of radial erosionon the base plate may be indicative of a radial progression of moistureto the first electrode pair and the second electrode pair (and not thethird electrode pair). The second operating state indicative of mediumdegree of radial erosion on the base plate may be indicative of a radialprogression of moisture to the first electrode pair and to the secondelectrode pair.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of resistance between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the secondthreshold values (TH_2_1, TH_2_2 and TH_2_3) may correspond to secondresistance threshold values. In one or more exemplary embodiments, thesecond primary threshold value TH_2_1 may correspond to an upperresistance threshold value. An upper resistance threshold value may beset to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms,such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. In one or more exemplaryembodiments, the second secondary threshold value TH_2_2 may correspondto the upper resistance threshold. In one or more exemplary embodiments,the second tertiary threshold value TH_2_3 may correspond to the upperresistance threshold value. In one or more exemplary embodiments, thesecond primary threshold value TH_2_1 may correspond to a mediumresistance threshold value. A medium resistance threshold value may beset to a value less than 10 Mega-Ohms, such as 5 Mega-Ohms, such as 3Mega-Ohms, such as 2 Mega-Ohms, such as 1 Mega-Ohms.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of voltage between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the secondthreshold values (TH_2_1, TH_2_2 and TH_2_3) may correspond to secondvoltage threshold values. In one or more exemplary embodiments, thesecond primary threshold value TH_2_1 may correspond to an upper voltagethreshold value. An upper voltage threshold value may be set to a valueless than 5 Volts, such as 3 Volts, such as 2.86 Volts. In one or moreexemplary embodiments, the second secondary threshold value TH_2_2 maycorrespond to the upper voltage threshold value. In one or moreexemplary embodiments, the second tertiary threshold value TH_2_3 maycorrespond to the upper voltage threshold value. In one or moreexemplary embodiments, the second primary threshold value TH_2_1 maycorrespond to a medium voltage threshold value. A medium resistancethreshold value may be set to a value less than 10 Mega-Ohms, such as 5Mega-Ohms, such as 3 Mega-Ohms, such as 2 Mega-Ohms, such as 1Mega-Ohms.

In one or more exemplary embodiments, the second criteria set maycomprise any of:

-   -   D_1_2_1>Z        wherein Z is a time difference constant characterizing the        progression of moisture (e.g. 3 h, e.g. 2 h).

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a default criteria set based on thefirst parameter data, wherein the operating state is determined to bethe default operating state if the default criteria set is satisfied,and in accordance with a determination that the operating state is thedefault operating state, transmit a default monitor signal comprisingmonitor data indicative of the default operating state of the ostomyappliance.

The default criteria set may be given by or at least may comprise:

-   -   (P_1_1>TH_D_1),    -   (P_2_1>TH_D_2), and    -   (P_3_1>TH_D_3)        wherein P_1_1 is a first primary parameter based on the first        parameter data and indicative of the resistance between the        first electrode pair, TH_D_1 is a default primary threshold        value, P_2_1 is a second primary parameter based on the second        parameter data and indicative of the resistance between the        second electrode pair, TH_D_2 is a default secondary threshold        value, P_3_1 is a third primary parameter based on the third        parameter data and indicative of the resistance between the        third electrode pair, TH_D_3 is a default tertiary threshold        value, and wherein the default operating state is indicative of        very low or no degree of radial erosion on the base plate. The        default threshold values (TH_D_1, TH_D_2 and TH_D_3) may be the        same or different, e.g. depending on the electrode configuration        of the base plate. In one or more exemplary embodiments, when        the first parameter data, the second parameter data and the        third parameter data are each respectively indicative of        resistance between the first electrode pair, the second        electrode pair and the third electrode pair respectively, the        default threshold values (TH_D_1, TH_D_2 and TH_D_3) may        correspond to default resistance threshold values. In one or        more exemplary embodiments, the second primary threshold value        TH_D_1 may correspond to an upper resistance threshold value. An        upper resistance threshold value may be set to a value which is        less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5        Mega-Ohms, such as 20.4 Mega-Ohms. In one or more exemplary        embodiments, the default secondary threshold value TH_D_2 may        correspond to the upper resistance threshold. In one or more        exemplary embodiments, the default tertiary threshold value        TH_D_3 may correspond to the upper resistance threshold value.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of voltage between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the defaultthreshold values (TH_D_1, TH_D_2 and TH_D_3) may correspond to defaultvoltage threshold values. In one or more exemplary embodiments, thedefault primary threshold value TH_D_1 may correspond to an uppervoltage threshold value. An upper voltage threshold value may be set toa value less than 5 Volts, such as 3 Volts, such as 2, 86 Volts. In oneor more exemplary embodiments, the default secondary threshold valueTH_D_2 may correspond to the upper voltage threshold value. In one ormore exemplary embodiments, the default tertiary threshold value TH_D_3may correspond to the upper voltage threshold value.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a third criteria set based on thethird parameter data, wherein the operating state is determined to bethe third operating state if the third criteria set is satisfied, and inaccordance with a determination that the operating state is the thirdoperating state, transmit a third monitor signal comprising monitor dataindicative of the third operating state of the ostomy appliance.

In one or more exemplary monitor devices, the third operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate has experienced a third degree of radialerosion, e.g. the first adhesive layer is eroded to the third radialdistance of the third electrode pair.

The third criteria set may be given by or at least may comprise:

-   -   (P_1_1<TH_3_1),    -   (P_2_1<TH_3_2), and    -   (P_3_1<TH_3_3)

wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_3_1 is a third primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_3_2 is a thirdsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_3_3 is a third tertiary threshold value, andwherein the third operating state is indicative of high degree of radialerosion on the base plate. The third threshold values (TH_3_1, TH_3_2and TH_3_3) may be the same or different, e.g. depending on theelectrode configuration of the base plate. The third primary criterion(P_1_1<TH_3_1) and/or the third secondary criterion (P_2_1<TH_3_2) maybe omitted in the third criteria set. The third operating stateindicative of high degree of radial erosion on the base plate may beindicative of high likelihood of leakage, e.g. on the proximal side ofthe base plate, e.g. within a time period e.g. within the next 20minutes. The third operating state may indicate a radial progression ofmoisture to the first electrode pair, the second electrode pair, and thethird electrode pair.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of resistance between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the thirdthreshold values (TH_3_1, TH_3_2 and TH_3_3) may correspond to thirdresistance threshold values. In one or more exemplary embodiments, thethird primary threshold value TH_3_1 may correspond to an upperresistance threshold value. In one or more exemplary embodiments, thethird secondary threshold value TH_3_2 may correspond to an upperresistance threshold value. In one or more exemplary embodiments, thethird tertiary threshold value TH_3_3 may correspond to an upperresistance threshold value. An upper resistance threshold value may beset to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms,such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms.

In one or more exemplary embodiments, the third primary threshold valueTH_3_1 may correspond to a lower resistance threshold value. In one ormore exemplary embodiments, a lower resistance threshold value may beset to a value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80kilo-Ohms, such as 79 kilo-Ohms. In one or more exemplary embodiments,the third secondary threshold value TH_3_2 may correspond to a mediumresistance threshold. A medium resistance threshold value may be set toa value less than 10 Mega-Ohms, such as 5 Mega-Ohms, such as 3Mega-Ohms, such as 2 Mega-Ohms, such as 1 Mega-Ohms. In one or moreexemplary embodiments, the third tertiary threshold value TH_3_3 maycorrespond to the upper resistance threshold. An upper resistancethreshold value may be set to a value which is less than 30 Mega-Ohms,such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms.

In one or more exemplary embodiments, when the first parameter data, thesecond parameter data and the third parameter data are each respectivelyindicative of voltage between the first electrode pair, the secondelectrode pair and the third electrode pair respectively, the thirdthreshold values (TH_3_1, TH_3_2 and TH_3_3) may correspond to thirdvoltage threshold values. In one or more exemplary embodiments, thethird primary threshold value TH_3_1 may correspond to an upper voltagethreshold value. In one or more exemplary embodiments, the thirdsecondary threshold value TH_3_2 may correspond to an upper voltagethreshold value. In one or more exemplary embodiments, the secondtertiary threshold value TH_2_3 may correspond to the upper voltagethreshold value.

In one or more exemplary embodiments, the third primary threshold valueTH_3_1 may correspond to a lower voltage threshold value. In one or moreexemplary embodiments, a lower voltage threshold value may be set to avalue which is less than 1 Volt, such as 0.5 Volt, such as 0.25 Volts,such as 0.22 Volts. In one or more exemplary embodiments, the thirdsecondary threshold value TH_3_2 may correspond to a medium voltagethreshold value. A medium voltage threshold value may be set to a valueless than 2 Volts, such as 1.5 Volts. In one or more exemplaryembodiments, the second tertiary threshold value TH_2_3 may correspondto the upper voltage threshold value.

In one or more exemplary embodiments, the third criteria set maycomprise any of:

-   -   D_2_3_1<Z        Wherein Z is a time difference constant characterizing the        progression of moisture (e.g. 3 h, e.g. 2 h), a time difference        D_1_2_1 between a time T1 where P_1_1 crosses TH_1_1 and a time        T2 where P_2_1 crosses TH_1_2, and a time difference D_2_3_1        between a time T2 where P_2_1 crosses TH_1_2 and a time T3 where        P_3_1 crosses TH_1_3.

In one or more exemplary monitor devices, the ostomy data comprisesfourth ostomy data from a fourth electrode pair of the base plate. Toapply a processing scheme may comprise to obtain fourth parameter databased on the fourth ostomy data, and determine an operating state of thebase plate of the ostomy appliance based on the fourth parameter data.The monitor device may be configured to, in accordance with adetermination that the operating state is a fourth operating state,transmit a fourth monitor signal comprising monitor data indicative ofthe fourth operating state of the ostomy appliance.

In one or more exemplary monitor devices, the fourth operating state ofthe base plate corresponds to a situation, wherein the fourth electrodepair detects fluid, such as output, between the proximal surface offirst adhesive layer and the skin of the user at a fourth radialdistance, and thus there is a high risk of leakage from the ostomyappliance in the fourth operating state.

The fourth criteria set may be given by or at least may comprise:

-   -   (P_4_1<TH_4_4)        wherein P_4_1 is a fourth primary parameter based on the fourth        parameter data and indicative of the resistance between the        fourth electrode pair and TH_4_4 is a fourth quaternary        threshold value, and wherein the fourth operating state is        indicative of high risk of leakage from the ostomy appliance.

In one or more exemplary embodiments, the fourth quaternary thresholdvalue TH_4_4 may correspond to an upper resistance threshold value.

In one or more exemplary monitor devices, a fifth operating state of thebase plate corresponds to a situation, wherein the fourth electrode pairdetects fluid, such as sweat, between the proximal surface of firstadhesive layer and the skin of the user at a fourth radial distance, andthus there is a no leakage from the ostomy appliance in the fifthoperating state.

The fifth operating state may be determined in accordance with adetermination that one or more fifth criterion of a fifth criteria setare satisfied by fourth parameter data.

The fifth criteria set may be given by or at least may comprise:

-   -   (P_4_1<TH_5_1)    -   (P_4_2<TH_5_2)    -   (P_4_3<TH_5_3)    -   (∇P_4_1<V)    -   (∇P_4_2<V) and    -   (∇P_4_3<V)

Wherein P_4_1 is a fourth primary parameter based on the fourthparameter data and indicative of the resistance between the fourthelectrode pair, P_4_2 is a fourth secondary parameter based on thefourth parameter data and indicative of the resistance between thefourth electrode and the fifth electrode, P_4_3 is a fourth tertiaryparameter based on the fourth parameter data and indicative of theresistance between the fifth electrode pair and TH_5_1 is a fifthprimary threshold value, TH_5_2 is a fifth secondary threshold valueTH_5_3 is a fifth tertiary threshold value and ∇P_4_1 is gradient ofP_4_1, ∇P_4_2 is gradient of P_4_2, VP_4_3 is gradient of P_4_3, and Vis a gradient limit (e.g. 80%). In one or more exemplary embodiments,the fifth primary threshold value TH_5_1 may correspond to an upperresistance threshold value. In one or more exemplary embodiments, TH_5_2may correspond to an upper resistance threshold value. n one or moreexemplary embodiments, TH_5_3 may correspond to an upper resistancethreshold value. An upper resistance threshold value may be set to avalue which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as20.5 Mega-Ohms, such as 20.4 Mega-Ohms. The fifth operating state mayrefer to presence of sweat detected by the fourth parameter dataindicating moisture detected omnidirectionally from the stomal openingand uniformly.

In one or more exemplary monitor devices, a sixth operating state of thebase plate corresponds to a situation, wherein the fourth electrode pairdetects fluid, such as output, between the proximal surface of firstadhesive layer and the skin of the user at a fourth radial distance, andthus there is a sudden leakage from the ostomy appliance in the sixthoperating state.

The sixth operating state may be determined in accordance with adetermination that one or more sixth criterion of a sixth criteria setare satisfied by the fourth parameter data.

The sixth criteria set may comprise a sixth primary criterion, whereinthe sixth primary criterion may comprise:

-   -   (P_4_1<TH_6_1) and    -   (∇P_4_1>V)

The sixth criteria set may comprise a sixth secondary criterion, whereinthe sixth secondary criterion may comprise:

-   -   (P_4_2<TH_6_2) and    -   (∇P_4_2>V)

The sixth criteria set may comprise a sixth tertiary criterion, whereinthe sixth tertiary criterion may comprise:

-   -   (P_4_3<TH_6_3) and    -   (∇P_4_3>V)        wherein P_4_1 is a fourth primary parameter based on the fourth        parameter data and indicative of the resistance between the        fourth electrode pair, P_4_2 is a fourth secondary parameter        indicative of the resistance between the fourth electrode and        the fifth electrode, P_4_3 is a fourth tertiary parameter        indicative of the resistance between the fifth electrode pair        (fifth electrode and ground electrode) and TH_6_1 is a sixth        primary threshold value, TH_6_2 is a sixth secondary threshold        value TH_6_3 is a sixth tertiary threshold value, and ∇P_4_1 is        gradient of P_4_1, ∇P_4_2 is gradient of P_4_2, ∇P_4_3 is        gradient of P_4_3, and V is a gradient limit (e.g. 80%). In one        or more exemplary embodiments, the sixth primary threshold value        TH_6_1 may correspond to an upper resistance threshold value. In        one or more exemplary embodiments, TH_6_2 may correspond to an        upper resistance threshold value. In one or more exemplary        embodiments, TH_6_3 may correspond to an upper resistance        threshold value. An upper resistance threshold value may be set        to a value which is less than 30 Mega-Ohms, such as 25        Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. The        sixth operating state may refer to presence of output detected        by the fourth parameter data indicating a sudden leak, e.g. a        developing leak. In one or more exemplary embodiments, when the        time T is below X minutes from the placement of the base plate,        where X is between 5 to 60 minutes, and when any of P_1_1,        P_2_1, P_3_1 in average over T are below a default threshold        value corresponding to an upper resistance threshold value, this        indicates that any of the first electrode pair, the second        electrode pair, and the third electrode pair is cut (e.g. cut by        the user when preparing the base plate for placement around the        stoma). In one or more exemplary embodiments, when the time T is        below X minutes from the placement of the base plate, where X is        between 5 to 60 minutes, and when any of P_4_1, P_4_2, P_4_3 in        average over T are below a default threshold value corresponding        to an upper resistance threshold value, this indicates an        instant leakage, e.g. presence of output on the proximal side.

In one or more exemplary embodiments, any of the first criteria set, thesecond criteria set, the third criteria set, the fourth criteria set,the default criteria set, the fifth criteria set, the sixth criteria setmay be used to define one or more further criteria sets, and thereby todetermine one or more operating states.

In one or more exemplary embodiments, different criteria sets may beused to determine the same operating state.

The monitor device comprises a monitor device housing optionally made ofa plastic material. The monitor device housing may be an elongatehousing having a first end and a second end. The monitor device housingmay have a length or maximum extension along a longitudinal axis in therange from 1 cm to 15 cm. The monitor device housing may have a width ormaximum extension perpendicular to the longitudinal axis in the rangefrom 0.5 cm to 3 cm. The monitor device housing may be curve-shaped.

The monitor device comprises a first interface. The first interface maybe configured as an appliance interface for electrically and/ormechanically connecting the monitor device to the ostomy appliance.Thus, the appliance interface is configured to electrically and/ormechanically couple the monitor device and the ostomy appliance. Thefirst interface may be configured as an accessory device interface forelectrically and/or mechanically connecting the monitor device to anaccessory device, such as a docking station. The first interface may beconfigured for coupling to a docking station of the ostomy system, e.g.for charging the monitor device and/or for data transfer between themonitor device and the docking station.

The first interface of the monitor device may comprise a plurality ofterminals, such as two, three, four, five, six, seven or more terminals,for forming electrical connections with respective terminals and/orelectrodes of the ostomy appliance. One or more terminals of the firstinterface may be configured for forming electrical connections with anaccessory device, e.g. with respective terminals of a docking station.The first interface may comprise a ground terminal. The first interfacemay comprise a first terminal, a second terminal and optionally a thirdterminal. The first interface may comprise a fourth terminal and/or afifth terminal. The first interface optionally comprises a sixthterminal. In one or more exemplary monitor devices, the first interfacehas M terminals, wherein M is an integer in the range from 4 to 8.

The first interface of the monitor device may comprise a coupling partfor forming a mechanical connection, such as a releasable couplingbetween the monitor device and the base plate. The coupling part and theterminals of the first interface form (at least part of) a firstconnector of the monitor device.

The monitor device comprises a power unit for powering the monitordevice. The power unit may comprise a battery. The power unit maycomprise charging circuitry connected to the battery and terminals ofthe first interface for charging the battery via the first interface,e.g. the first connector. The first interface may comprise separatecharging terminal(s) for charging the battery.

The monitor device may comprise a sensor unit with one or more sensor.The sensor unit is connected to the processor for feeding sensor data tothe processor. The sensor unit may comprise an accelerometer for sensingacceleration and provision of acceleration data to the processor. Thesensor unit may comprise a temperature sensor for provision oftemperature data to the processor.

The monitor device comprises a second interface connected to theprocessor. The second interface may be configured as an accessoryinterface for connecting, e.g. wirelessly connecting, the monitor deviceto one or more accessory devices. The second interface may comprise anantenna and a wireless transceiver, e.g. configured for wirelesscommunication at frequencies in the range from 2.4 to 2.5 GHz. Thewireless transceiver may be a Bluetooth transceiver, i.e. the wirelesstransceiver may be configured for wireless communication according toBluetooth protocol, e.g. Bluetooth Low Energy, Bluetooth 4.0, Bluetooth5. The second interface optionally comprises a loudspeaker and/or ahaptic feedback element for provision of an audio signal and/or hapticfeedback to the user, respectively.

In one or more exemplary ostomy systems, the monitor device forms anintegrated part of the ostomy appliance, e.g. the monitor device mayform an integrated part of a base plate of the ostomy appliance.

The ostomy system may comprise a docking station forming an accessorydevice of the ostomy system. The docking station may be configured toelectrically and/or mechanically couple the monitor device to thedocking station.

The docking station may comprise a docking monitor interface. Thedocking monitor interface may be configured for electrically and/ormechanically connecting the monitor device to the docking station. Thedocking monitor interface may be configured for wirelessly connectingthe monitor device to the docking station. The docking monitor interfaceof the docking station may be configured to electrically and/ormechanically couple the docking station and the monitor device.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, acoupling part for forming a mechanical connection, such as a releasablecoupling between the monitor device and the docking station. Thecoupling part may be configured to engage with a coupling part of themonitor device for releasably coupling the monitor device to the dockingstation.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, aplurality of terminals, such as two, three, four, five, six, seven ormore terminals, for forming electrical connections with respectiveterminals of the monitor device. The docking monitor interface maycomprise a ground terminal. The docking monitor interface may comprise afirst terminal and/or a second terminal. The docking station maycomprise a third terminal. The docking monitor interface may comprise afourth terminal and/or a fifth terminal. The docking monitor interfaceoptionally comprises a sixth terminal.

The present disclosure includes calibration methods for ostomy systems.A method for operating an accessory device to capture calibration datais disclosed. The method may be seen as a method for calibrating datacaptured by an accessory device so as to operate the accessory device,e.g. for placement and preparation of an ostomy appliance to be used onthe stoma of a user. The method includes capturing an image of a portionof a user's body that includes the user's stoma and at least tworeference locations. The method includes storing distance scaleinformation representative of a distance between the two referencelocations, and processing the captured image, including: identifying thereference locations, identifying the stoma, and generating calibrationdata representative of one or more stoma parameters as a function of theidentified reference locations, identified stoma and the distance scaleinformation. Identifying the reference locations and/or identifying thestoma may be performed using machine learning. The method furtherincludes storing the calibration data. The method may further comprisegenerating the distance scale information. The distance scaleinformation may refer to an actual size of the distance between the tworeference locations in a numerical value (e.g., 3 inches). The actualsize can be calculated based on a number of pixels disposed between thetwo reference locations. The calibration data may include one or more ofstoma size data, stoma orientation data, stoma location data, and stomashape data. The stoma size data may refer to information associated withan actual size of the stoma. The stoma orientation data may refer toinformation associated with a relative physical position or direction ofthe stoma in relation to the user's body. The stoma location data mayrefer to information associated with an actual location of the stoma inrelation to the user's body. The stoma shape data may refer toinformation associated with external appearance characteristics of thestoma. A method for operating an accessory device to capture ostomycalibration data is disclosed. The method includes capturing an image ofa portion of a user's body that includes the user's stoma and at leasttwo reference locations, storing distance scale informationrepresentative of a distance between the two reference locations, andprocessing the captured image, including: identifying the referencelocations, identifying the stoma, and generating size datarepresentative of a size of the stoma as a function of the identifiedreference locations, identified stoma and the distance scaleinformation. The method further includes storing the size data.

A method for operating an accessory device to capture calibration datais disclosed. The method includes capturing an image of a portion of auser's body that includes the user's stoma and at least two referencelocations, wherein at least one of the reference locations includes afeature of the user's body at a location spaced apart from the stoma.The method further includes storing distance scale informationrepresentative of a distance between the two reference locations, andprocessing the captured image, including: identifying the referencelocations, identifying the stoma, and generating calibration datarepresentative of a location of the stoma with respect to the feature ofthe user's body as a function of the identified reference locations,identified stoma and the distance scale information. The method alsoincludes storing the calibration data.

A method for operating an accessory device to capture ostomy calibrationdata is disclosed. The method includes capturing an image of a portionof a user's body that includes the user's stoma and at least tworeference locations, storing distance scale information representativeof a distance between the two reference locations, and processing thecaptured image, including: identifying the reference locations,identifying the stoma, and generating shape data representative of ashape of the stoma as a function of the identified reference locations,identified stoma and the distance scale information. The method furtherincludes storing the shape data.

A method for operating an accessory device to capture ostomy calibrationdata is disclosed. The method includes capturing an image of a portionof a user's body that includes the user's stoma and at least tworeference locations, storing distance scale information representativeof a distance between the two reference locations, and processing thecaptured image, including: identifying the reference locations,identifying the stoma, and generating orientation data representative ofan orientation of the stoma as a function of the identified referencelocations, identified stoma and the distance scale information. Themethod further includes storing the orientation data.

The calibration data may include one or more of stoma size data, stomaorientation data, stoma shape data and stoma location data. The methodmay further include receiving the distance scale information through auser interface. The at least two reference locations can include atleast two spaced-apart features of the user's body. The at least tworeference locations can include at least two spaced-apart features ofthe user's stoma. The at least two reference locations can bespaced-apart marks applied to the user's body. The at least two markscan include two marks on a substrate on the user's body. The two markscan be on a substrate removed from an ostomy appliance. The two markscan be on a substrate adhesively attached to the user's body.

A user interface refers herein to a graphical representation comprisinga collection of user interface objects. A user interface comprises oneor more user interface objects. A user interface may be referred to as auser interface screen.

A user interface object refers herein to a graphical representation ofan object that is displayed on the display of the accessory device. Theuser interface object may be user-interactive, or selectable by a userinput. For example, an image (e.g., icon), a button, and text (e.g.,hyperlink) each optionally constitute a user interface object. The userinterface object may form part of a widget. A widget may be seen as amini-application that may be used by the user, and created by the user.A user interface object may comprise a prompt, application launch icon,and/or an action menu. An input, such as first input and/or secondinput, may comprise a touch (e.g. a tap, a force touch, a long press), aand/or movement of contact (e.g. a swipe gesture, e.g. for toggling).The movement on contact may be detected by a touch sensitive surface,e.g. on a display of an accessory device. Thus, the display may be atouch sensitive display. An input, such as first input and/or secondinput, may comprise a lift off. An input, such as first input and/orsecond input, may comprise a touch and a movement followed by a liftoff.

The display of the accessory device may be configured to detect touch(e.g. the display is a touch-sensitive display), the input comprises acontact on the touch sensitive display. A touch-sensitive displayprovides an input interface and an output interface between theaccessory device and a user. A processor of the accessory device may beconfigured to receive and/or send electrical signals from/totouch-sensitive display. A touch-sensitive display is configured todisplay visual output to the user. The visual output optionally includesgraphics, text, icons, video, and any combination thereof (collectivelytermed “graphics”). For example, some or all of the visual output may beseen as corresponding to user-interface objects.

The processor of the accessory device may be configured to display, onthe display, one or more user interfaces, such as user interfacescreens, including a first user interface and/or a second userinterface. A user interface may comprise one or more, such as aplurality of user interface objects. For example, the first userinterface may comprise a first primary user interface object and/or afirst secondary user interface object. A second user interface maycomprise a second primary user interface object and/or a secondsecondary user interface object. A user interface object, such as thefirst primary user interface object and/or the second primary userinterface object, may represent an operating state of the base plate.

The at least two reference locations can include: at least one featureof the user's body, and at least one mark applied to the user's body.The at least one mark can include at least one mark on a substratepositioned on the user's body. The at least one mark can be on asubstrate removed from an ostomy appliance. The at least one mark can beon a substrate adhesively attached to the user's body.

Processing the captured image can further include determining locationdata representative of a location of the stoma with respect to at leastone of the reference locations. The method may further include storingthe determined location data.

Processing the captured image can further includes determiningorientation data representative of an orientation of the stoma withrespect to at least one of the reference locations. The method mayfurther include storing the determined orientation data.

Processing the captured image can further include determining shape datarepresentative of the shape of the stoma. The method may further includestoring the determined shape data.

Capturing an image that includes at least two reference locations caninclude capturing an image of an ostomy appliance including the at leasttwo reference locations. The method may further include determining thedistance between the at least two reference locations on the image ofthe ostomy appliance.

Determining the distance between the at least two reference locations onthe image can include receiving information through a user interface.Storing distance scale information can include storing informationrepresentative of the distance between reference locations on each ofone or more ostomy appliances. Receiving information through a userinterface can include receiving information representative of the imagedostomy appliance. Determining the distance between the at least tworeference locations on the image can include accessing the storeddistance scale information using the received information representativeof the imaged ostomy appliance.

At least one feature of the user's body can include a feature of theuser's stoma. Processing the captured image can further includedetermining size data representative of the size of the stoma. Themethod may further include storing the determined size data. Capturingthe image, storing the scale information, processing the image andstoring the calibration data can be performed by an accessory deviceincluding a camera, image processor and display device.

An accessory device configured to provide calibration methods for ostomysystems is disclosed. The accessory device includes a camera, imageprocessor, display and stored instructions for performing any of thesteps of the methods described herein. The accessory device can includea processor, a memory, a camera, an input device, and at least onedisplay device. The memory, camera, input device and display device areoperatively and communicably coupled to the processor for transmittingand receiving data. A bus can be used to mutually communicate betweenvarious components associated with the accessory device, such as theprocessor, the memory, the camera, and the input device. The cameracaptures one or more images and generates image data for subsequentrendering and processing.

Included in the processor is an appliance calibration unit configured togenerate calibration data for ostomy appliance tools. The cameracaptures an image of a portion of a user's body that includes the user'sstoma and at least two reference locations. The memory stores distancescale information representative of a distance between the two referencelocations. The appliance calibration unit processes the captured image.The appliance calibration unit identifies the reference locations,identifies the stoma, and generates calibration data representative ofone or more stoma parameters as a function of the identified referencelocations, identified stoma and the distance scale information. Thememory further stores the calibration data.

The camera captures an image of a portion of a user's body that includesthe user's stoma and at least two reference locations. The memory storesdistance scale information representative of a distance between the tworeference locations. The appliance calibration unit processes thecaptured image. The appliance calibration unit identifies the referencelocations, identifies the stoma, and generates size data representativeof a size of the stoma as a function of the identified referencelocations, identified stoma and the distance scale information. Thememory further stores the size data.

The camera captures an image of a portion of a user's body that includesthe user's stoma and at least two reference locations, wherein at leastone of the reference locations includes a feature of the user's body ata location spaced apart from the stoma. The memory stores distance scaleinformation representative of a distance between the two referencelocations. The appliance calibration unit processes the captured image.The appliance calibration unit identifies the reference locations,identifies the stoma, and generates calibration data representative of alocation of the stoma with respect to the feature of the user's body asa function of the identified reference locations, identified stoma andthe distance scale information. The memory also stores the calibrationdata.

The camera captures an image of a portion of a user's body that includesthe user's stoma and at least two reference locations. The memory storesdistance scale information representative of a distance between the tworeference locations. The appliance calibration unit processes thecaptured image. The appliance calibration unit identifies the referencelocations, identifies the stoma, and generates shape data representativeof a shape of the stoma as a function of the identified referencelocations, identified stoma and the distance scale information. Thememory further stores the shape data.

The camera captures an image of a portion of a user's body that includesthe user's stoma and at least two reference locations. The memory storesdistance scale information representative of a distance between the tworeference locations. The appliance calibration unit processes thecaptured image. The appliance calibration unit identifies the referencelocations, identifies the stoma, and generates orientation datarepresentative of an orientation of the stoma as a function of theidentified reference locations, identified stoma and the distance scaleinformation. The memory further stores the orientation data.

The calibration data may include one or more of stoma size data, stomaorientation data, stoma shape data and stoma location data. Theappliance calibration unit may receive the distance scale informationthrough a user interface (e.g., an interactive screen). The at least tworeference locations can include at least two spaced-apart features ofthe user's body. The at least two reference locations can include atleast two spaced-apart features of the user's stoma. The at least tworeference locations can be spaced-apart marks applied to the user'sbody. The at least two marks can include two marks on a substrate on theuser's body. The two marks can be on a substrate removed from an ostomyappliance. The two marks can be on a substrate adhesively attached tothe user's body.

The at least two reference locations can include: at least one featureof the user's body, and at least one mark applied to the user's body.The at least one mark can include at least one mark on a substratepositioned on the user's body. The at least one mark cab be on asubstrate removed from an ostomy appliance. The at least one mark can beon a substrate adhesively attached to the user's body. The at least onefeature of the user's body may include a feature of the user's stoma.

The appliance calibration unit can determine location datarepresentative of a location of the stoma with respect to at least oneof the reference locations. The memory can store the determined locationdata.

The appliance calibration unit can determine orientation datarepresentative of an orientation of the stoma with respect to at leastone of the reference locations. The memory can store the determinedorientation data.

The appliance calibration unit can determine shape data representativeof the shape of the stoma. The memory can store the determined shapedata.

The camera can capture an image of an ostomy appliance including the atleast two reference locations. The appliance calibration unit maydetermine the distance between the at least two reference locations onthe image of the ostomy appliance.

The appliance calibration unit can receive information through a userinterface (e.g., an interactive screen). The memory can storeinformation representative of the distance between reference locationson each of one or more ostomy appliances. The appliance calibration unitcan receive information representative of the imaged ostomy appliance.The appliance calibration unit can access the stored distance scaleinformation using the received information representative of the imagedostomy appliance. The appliance calibration unit can determine size datarepresentative of the size of the stoma. The memory can store thedetermined size data.

One or more computer-readable media have computer-executableinstructions embodied thereon. The computer-executable instructions areconfigured to cause at least one processor, upon being executed by theat least one processor, to perform any of the methods related to thecalibration methods for ostomy appliance tools described above.

FIG. 1 illustrates an exemplary ostomy system. The ostomy system 1comprises an ostomy appliance 2 including a base plate 4 and an ostomypouch (not shown). Further, the ostomy system 1 comprises a monitordevice 6 and an accessory device 8 (mobile telephone). The monitordevice 6 is connectable to the base plate 4 via respective firstconnectors of the monitor device 6 and base plate 4. The monitor device6 is configured for wireless communication with the accessory device 8.Optionally, the accessory device 8 is configured to communicate with aserver device 10 of the ostomy system 1, e.g. via network 12. The serverdevice 10 may be operated and/or controlled by the ostomy appliancemanufacturer and/or a service centre. Ostomy data or parameter databased on the ostomy data are obtained from electrodes/sensors of theostomy appliance 2 with the monitor device 6. The monitor device 6processes the ostomy data and/or parameter data based on the ostomy datato determine monitor data that are transmitted to the accessory device8. In the illustrated ostomy system, the accessory device 8 is a mobilephone, however the accessory device 8 may be embodied as anotherhandheld device, such as a tablet device, or a wearable, such as a watchor other wrist-worn electronic device. Accordingly, the monitor device 6is configured to determine and transmit monitor data to the accessorydevice 8. The base plate 4 comprises a coupling member 14 in the form ofa coupling ring 16 for coupling an ostomy pouch (not shown) to the baseplate (two-part ostomy appliance). The base plate 4 has a stomal opening18 with a stoma center point 19. The size and/or shape of the stomalopening 18 is typically adjusted by the user or nurse before applicationof the ostomy appliance to accommodate the user's stoma.

The ostomy system 1 optionally comprises a docking station 20 forming anaccessory device of the ostomy system 1. The docking station comprises20 comprises a docking monitor interface including a first connector 22configured for electrically and/or mechanically connecting the monitordevice 6 to the docking station 20. The docking monitor interface may beconfigured for wirelessly connecting the monitor device to the dockingstation. The docking station 20 comprises a user interface 24 forreceiving user input and/or providing feedback to the user on theoperational state of the docking station 20. The user interface 24 maycomprise a touch-screen. The user interface 24 may comprise one or morephysical buttons and/or one or more visual indicators, such as lightemitting diodes,

FIG. 2 is a schematic block diagram of an exemplary monitor device. Themonitor device 6 comprises a monitor device housing 100, a processor 101and one or more interfaces, the one or more interfaces including a firstinterface 102 (appliance interface) and a second interface 104(accessory interface). The monitor device 6 comprises a memory 106 forstoring ostomy data and/or parameter data based on the ostomy data. Thememory 106 is connected to the processor 101 and/or the first interface102.

The first interface 102 is configured as an appliance interface forelectrically and/or mechanically connecting the monitor device 6 to theostomy appliance, e.g. ostomy appliance 2. The first interface 102comprises a plurality of terminals for forming electrical connectionswith respective terminals of the ostomy appliance 2 (base plate 4). Thefirst interface 102 comprises a ground terminal 108, a first terminal110, a second terminal 112 and a third terminal 114. The first interface102 optionally comprises a fourth terminal 116 and a fifth terminal 118.The first interface 102 of the monitor device 6 comprises a couplingpart 120 for forming a mechanical connection, such as a releasablecoupling between the monitor device and the base plate. The couplingpart 120 and the terminals 108, 110, 112, 114, 116, and 118 of the firstinterface 102 form (at least part of) a first connector of the monitordevice 6.

The monitor device 6 comprises a power unit 121 for powering the monitordevice and active components thereof, i.e. the power unit 121 isconnected to the processor 101, the first interface 102, the secondinterface 104, and memory 106. The power unit comprises a battery andcharging circuitry. The charging circuitry is connected to the batteryand terminals of the first interface 102 for charging the battery viaterminals of the first interface, e.g. terminals of the first connector.

The second interface 104 of monitor device is configured as an accessoryinterface for connecting the monitor device 6 to one or more accessorydevices such as accessory device 8. The second interface 104 comprisesan antenna 122 and a wireless transceiver 124 configured for wirelesscommunication with accessory device(s). Optionally, the second interface104 comprises a loudspeaker 126 and/or a haptic feedback element 128 forprovision of respective audio signal and/or haptic feedback to the user.

The monitor device 6 optionally comprises a sensor unit 140 connected tothe processor 101. The sensor unit 140 comprises a temperature sensorfor feeding temperature data to the processor and/or a G-sensor oraccelerometer for feeding acceleration data to the processor 101.

The processor 101 is configured to apply a processing scheme, and thefirst interface 102 is configured for collecting ostomy data from thebase plate coupled to the first interface, the ostomy data comprisingfirst ostomy data from a first electrode pair of the base plate, secondostomy data from a second electrode pair of the base plate, and thirdostomy data from a third electrode pair of the base plate. The ostomydata may be stored in the memory 106 and/or processed in the processor101 in order to obtain parameter data. The parameter data may be storedin the memory 106. The processor 101 is configured to apply a processingscheme, wherein to apply a processing scheme comprises obtain firstparameter data based on the first ostomy data; obtain second parameterdata based on the second ostomy data; obtain third parameter data basedon the third ostomy data. In other words, the processor 101 isconfigured to obtain first, second and third parameter data based onrespective first, second and third ostomy data. To apply a processingscheme comprises to determine an operating state of the base plate ofthe ostomy appliance based on one or more, e.g. all, of the firstparameter data, the second parameter data and the third parameter data,wherein the operating state is indicative of a degree of radial erosionof the base plate and/or acute leakage risk for the ostomy appliance.The monitor device 6 is configured to, in accordance with adetermination that the operating state is a first operating state,transmit a first monitor signal comprising monitor data indicative ofthe first operating state of the base plate via the second interface;and in accordance with a determination that the operating state is asecond operating state, transmit a second monitor signal comprisingmonitor data indicative of the second operating state of the base platevia the second interface.

The monitor device 100 is configured to obtain ostomy data from the baseplate coupled to the first interface 102. The ostomy data may be storedin the memory 106 and/or processed in the processor 101 in order toobtain parameter data based on the ostomy data.

FIG. 3 illustrates an exploded view of an exemplary base plate of anostomy appliance. The base plate 4 comprises a first adhesive layer 200with a stomal opening 18A. During use, a proximal surface of the firstadhesive layer 200 adheres to the user's skin in the peristomal areaand/or to additional seals, such as sealing paste, sealing tape and/orsealing ring. The base plate 4 optionally comprises a second adhesivelayer 202, also denoted rim adhesive layer. The base plate 4 comprises aplurality of electrodes arranged in an electrode assembly 204. Theelectrode assembly 204 is arranged between the first adhesive layer 200and the second adhesive layer 202 with a stomal opening 18B. Theelectrode assembly 204 comprises a support layer with stomal opening 18Cand electrodes formed on a proximal surface of the support layer. Thebase plate 4 comprises a release liner 206 that is peeled off by theuser prior to applying the base plate 4 on the skin. The base plate 4comprises a top layer 208 with a stomal opening 18D and a coupling ring209 for coupling an ostomy pouch to the base plate 4. The top layer 208is a protective layer protecting the second adhesive layer 202 fromexternal strains and stress during use.

The base plate 4 comprises a monitor interface. The monitor interface isconfigured for electrically and/or mechanically connecting the ostomyappliance (base plate 4) to the monitor device. The monitor interface ofthe base plate comprises a coupling part 210 for forming a mechanicalconnection, such as a releasable coupling between the monitor device andthe base plate. The coupling part 210 is configured to engage with acoupling part of the monitor device for releasably coupling the monitordevice to the base plate 4. Further, the monitor interface of the baseplate 4 comprises a plurality of terminal elements respectively forminga plurality of terminals 212 for forming electrical connections withrespective terminals of the monitor device. The coupling part 210 andthe terminals 212 form a first connector 211 of the base plate 4. Thebase plate 4 comprises a first intermediate element 213 on the distalside of the electrode assembly. The first intermediate element 213 isarranged between the terminal elements forming terminals 212 and thefirst adhesive layer (not shown). The first intermediate element 213covers the terminal elements forming terminals 212 of the base plate 4when seen in the axial direction and protects the first adhesive layerfrom mechanical stress from the terminal elements of the base plate.

FIG. 4 illustrates an exploded view of an exemplary electrode assembly204 of a base plate. The electrode assembly 204 has a distal side 204Aand a proximal side 204B. The electrode assembly 204 comprises a supportlayer 214 with proximal surface 214B and electrodes 216 arranged on theproximal side of the support layer 214 and including a ground electrode,a first electrode, a second electrode, a third electrode, a fourthelectrode, and a fifth electrode, wherein each electrode has arespective connection part 217 for connecting the electrodes 216 torespective terminal elements of the monitor interface. The electrodes216 are positioned and/or formed on a proximal side 214B of the supportlayer 214. Further, electrode assembly 204 comprises a masking element218 with proximal surface 218B and configured to insulate electrodeparts of electrodes 216 from the first adhesive layer of the base plate.The masking element 218 covers or overlap with parts of the electrodes216 when seen in the axial direction.

FIG. 5 is a proximal view of proximal surfaces of base plate parts ofthe base plate without the first adhesive layer and the release liner.The base plate 4 comprises a first intermediate element 213 on thedistal side of the electrode assembly, i.e. between the electrodeassembly 204 and the first adhesive layer (not shown). The firstintermediate element 213 covers the terminal elements of the base plate4 when seen in the axial direction and protects the first adhesive layerfrom mechanical stress from the terminal elements of the base plate.

FIG. 6 is a distal view of an exemplary electrode configuration 220 ofelectrodes 216 of the electrode assembly 204. The electrodeconfiguration 220/electrode assembly 204 comprises a ground electrode222, a first electrode 224, a second electrode 226, a third electrode228, a fourth electrode 230, and a fifth electrode 232. The groundelectrode 222 comprises a ground connection part 222A and the firstelectrode 224 comprises a first connection part 224A. The secondelectrode 226 comprises a second connection part 226A and the thirdelectrode 228 comprises a third connection part 228A. The fourthelectrode 230 comprises a fourth connection part 230A and the fifthelectrode 232 comprise a fifth connection part 232A.

The fourth electrode 230 comprises fourth sensing parts 230B. The fifthelectrode 232 comprises fifth sensing parts 232B.

The ground electrode 222 comprises a first electrode part 234 forforming a ground or reference for the first electrode 224. The groundelectrode 222 comprises a second electrode part 236 for forming a groundor reference for the second electrode 226. The ground electrode 222comprises a third electrode part 238 for forming a ground or referencefor the third electrode 228. The masking element 218 is arrangedproximal to the electrodes 222, 224, 226, 228 covering and insulatingparts of the electrodes from the first adhesive and forming respectiveconductor parts of the electrodes 222, 224, 226, 228. The parts of theelectrodes 222, 224, 226, 228 not covered by the masking element 219contacts the first adhesive layer and form sensing parts 224B, 226B,228B of electrodes 224, 226, 228, respectively. Further, the electrodeparts 234, 236, 238 form sensing parts of the ground electrode 222.

The first sensing part 224B extends circularly at least 330 degreesaround the stomal opening at a first radial distance R1 from the centerpoint 19. The first radial distance R1 is 14 mm. The first electrodepart 234 is arranged on the inside of the first sensing part (i.e.closer to the center point) and extends circularly at least 330 degreesaround the stomal opening at a first ground distance RG1 from the firstsensing part (radially from the center point). The first ground distanceRG1 between sensing part of first electrode and first electrode part isabout 1 mm.

The second sensing part 226B extends circularly at least 330 degreesaround the stomal opening at a second radial distance R2 from the centerpoint 19. The second radial distance R2 is 18 mm. The second electrodepart 236 is arranged on the inside of the second sensing part 226B (i.e.closer to the center point) and extends circularly at least 330 degreesaround the stomal opening at a second ground distance RG2 from thesecond sensing part 226B (radially from the center point). The secondground distance RG2 between sensing part of second electrode and secondelectrode part is about 1 mm.

The third sensing part 228B extends circularly at least 330 degreesaround the stomal opening at a third radial distance R3 from the centerpoint 19. The third radial distance R3 is about 26 mm. The thirdelectrode part 238 is arranged on the inside of the third sensing part228B (i.e. closer to the center point) and extends circularly at least330 degrees around the stomal opening at a third ground distance RG3from the third sensing part 228B (radially from the center point). Thethird ground distance RG3 between sensing part of third electrode andthird electrode part is about 1 mm.

The ground electrode 222 comprises a fourth electrode part 240 forforming a ground or reference for the fourth electrode 230 and the fifthelectrode 232. The fourth electrode part 240 of the ground electrode 222extends at least 300 degrees around the stomal opening and comprisesground sensing parts 222B. The fourth sensing parts 230B, fifth sensingparts 232B, and ground sensing parts of the fourth electrode part 240are circularly distributed around the center point 19 at a leakageradius from the center point. The fourth sensing parts 230B, fifthsensing parts 232B, and ground sensing parts of the fourth electrodepart may have a radial extension larger than 1.0 mm, such as in therange from 1.5 mm to 3.0 mm, e.g. about 2.0 mm. The fourth sensing parts230B, fifth sensing parts 232B, and ground sensing parts of the fourthelectrode part 240 may have a circumferential extension (perpendicularto the radial extension) larger than 1.0 mm, such as in the range from2.5 mm to 5.0 mm, e.g. about 3.5 mm.

The ground electrode 222 comprises a first electrode part 234 forforming a ground for the first electrode 224. The ground electrode 222comprises a second electrode part 236 for forming a ground for thesecond electrode 226. The ground electrode 222 comprises a thirdelectrode part 238 for forming a ground for the third electrode 228. Theground electrode 222 comprises a fourth electrode part 240 for forming aground for the fourth electrode 230 and the fifth electrode 232. Thefourth electrode part 240 of the ground electrode 222 comprises groundsensing parts 222B.

FIG. 7 is a distal view of an exemplary masking element. The maskingelement 218 optionally has a plurality of terminal openings includingsix terminal openings. The plurality of terminal openings comprises aground terminal opening 242, a first terminal opening 244, a secondterminal opening 246, a third terminal opening 248, a fourth terminalopening 250, and a fifth terminal opening 252. The terminal openings242, 244, 246, 248, 250, 252 of the masking element 218 are configuredto overlap and/or be aligned with respective connection parts 222A,224A, 226A, 228A, 230A, 232A of the electrodes of the electrodeassembly.

The masking element 218 has a plurality of sensor point openings. Thesensor point openings comprise primary sensor point openings shownwithin dotted line 254, each primary sensor point opening configured tooverlap a part of the ground electrode 222 and/or a part of the fourthelectrode 230. The primary sensor point openings 254 comprise, in theillustrated exemplary masking element, five primary first sensor pointopenings 254A each configured to overlap a part of the ground electrode222. The primary sensor point openings 254 comprise, in the illustratedexemplary masking element, four primary second sensor point openings254B each configured to overlap a part of the fourth electrode 230. Thesensor point openings comprise secondary sensor point openings shownwithin dotted line 256, each second sensor point opening configured tooverlap a part of the fourth electrode 230 and/or a part of the fifthelectrode 232. The secondary sensor point openings 256 comprise, in theillustrated exemplary masking element, five secondary first sensor pointopenings 256A each configured to overlap a part of the fifth electrode232. The secondary sensor point openings 256 comprise, in theillustrated exemplary masking element, four secondary second sensorpoint openings 256B each configured to overlap a part of the fourthelectrode 230. The sensor point openings comprise tertiary sensor pointopenings shown within dotted line 258, each tertiary sensor openingconfigured to overlap a part of the fifth electrode 232 and/or a part ofthe ground electrode 222. The tertiary sensor point openings 258comprise, in the illustrated exemplary masking element, five tertiaryfirst sensor point openings 258A each configured to overlap a part ofthe fifth electrode 232. The tertiary sensor point openings 258comprise, in the illustrated exemplary masking element, four tertiarysecond sensor point openings 258B each configured to overlap a part ofthe ground electrode 222.

FIG. 8 is a distal view of an exemplary first adhesive layer. The firstadhesive layer 200 has a plurality of sensor point openings. The sensorpoint openings of the first adhesive layer comprise primary sensor pointopenings shown within dotted line 260, each primary sensor point openingconfigured to overlap a part of the ground electrode 222 and/or a partof the fourth electrode 230 of the electrode assembly. The primarysensor point openings 260 comprise, in the illustrated exemplary firstadhesive layer, five primary first sensor point openings 260A eachconfigured to overlap a part of the ground electrode 222. The primarysensor point openings 260 comprise, in the illustrated exemplary firstadhesive layer, four primary second sensor point openings 260B eachconfigured to overlap a part of the fourth electrode 230. The sensorpoint openings of the first adhesive layer comprise secondary sensorpoint openings shown within dotted line 262, each second sensor pointopening configured to overlap a part of the fourth electrode 230 and/ora part of the fifth electrode 232 of the electrode assembly. Thesecondary sensor point openings 262 comprise, in the illustratedexemplary first adhesive layer, five secondary first sensor pointopenings 262A each configured to overlap a part of the fifth electrode232. The secondary sensor point openings 262 comprise, in theillustrated exemplary first adhesive layer, four secondary second sensorpoint openings 262B each configured to overlap a part of the fourthelectrode 230. The sensor point openings of the first adhesive layercomprise tertiary sensor point openings shown within dotted line 264,each tertiary sensor opening configured to overlap a part of the fifthelectrode 232 and/or a part of the ground electrode 222 of the electrodeassembly. The tertiary sensor point openings 264 comprise, in theillustrated exemplary first adhesive layer, five tertiary first sensorpoint openings 264A each configured to overlap a part of the fifthelectrode 232. The tertiary sensor point openings 264 comprise, in theillustrated exemplary first adhesive layer, four tertiary second sensorpoint openings 264B each configured to overlap a part of the groundelectrode 222. FIG. 9 is a proximal view of the first adhesive layer ofFIG. 8 .

FIG. 10 is a more detailed distal view of a part of the base plate 4.Monitor interface of the base plate comprises the first connector 211.The first connector 211 comprises coupling part 210 configured toreleasably couple the monitor device to the base plate and thus forminga releasable coupling. The first connector 221/monitor interfacecomprises a plurality of terminals formed by respective terminalelements for forming respective electrical connections with respectiveterminals of the monitor device.

The plurality of terminals of the first connector 211/monitor interfacecomprises a ground terminal element 282 forming a ground terminal 282A,a first terminal element 284 forming a first terminal 284, a secondterminal element 286 forming a second terminal 286A, and optionally athird terminal element 288 forming a third terminal 288A. The monitorinterface optionally comprises a fourth terminal element 290 forming afourth terminal 290A and/or a fifth terminal element 292 forming a fifthterminal 290. The terminal elements 282, 284, 286, 288, 290, 292 contactrespective connection parts 222A, 224A, 226A, 228A, 230 a, 232A ofelectrodes 222, 224, 226, 228, 230, 232.

The position of the first connector on the base plate, the number ofterminals and the position of the terminals in the coupling part may beadapted to the electrode configuration used in the electrode assembly ofthe base plate.

FIG. 11 is an illustrative block diagram representing the accessorydevice 8 configured to provide a hole cutting process of the ostomyappliance 2 for a user (e.g. to provide a hole cutting assistance orguidance, e.g. to provide a stoma opening cutting assistance orguidance). It may be seen that the accessory device 8 is configured toprovide assistance in preparing an ostomy appliance for use. It isadvantageous that this hole cutting process or preparation of the ostomyappliance 2 aids the user to prepare the ostomy appliance 2, such as toproperly cut a hole in the ostomy appliance 2 with less difficulty ordiscomfort and greater accuracy for improved operation of the ostomyappliance 2. The accessory device 8 has peripheral devices, such as aprocessor 300, a memory 302, an imaging device, such as a camera, 304,an input device 306, and at least one display device 308A, 308B, 308C(collectively 308). Peripheral devices 302, 304, 306, 308 can beoperatively and communicably coupled to the processor 300 via a bus 310for transmitting and receiving data. The processor 300 can be a centralprocessing unit (CPU), but other suitable microprocessors are alsocontemplated.

The camera 304 captures one or more images and generates image data forsubsequent rendering and processing. At least a portion of the imagedata is displayed on one or more display devices 308 for viewing. Thedisplay device 308 can be a touch screen or a monitor, or the like. Theinput device 306 can be a keyboard or an interactive screen forinputting data, such as alphabetical and/or numerical characters. Inputdata can be temporarily or permanently stored in the memory 302 or anyother suitable database. Other data processed by one or more of theunits 312, 314, 316 can also be stored in the memory 302. Calibrationdata 318, size data 319, orientation data 320, location data 321, andshape data 322 are stored in the memory 302 for subsequent processing.

Further included in the processor 300 are a stomal opening cutting unit312, an appliance guidance unit 314, and an appliance calibration unit316. Units 312, 314, 316 can be mutually communicable via the bus 310for processing relevant data. Detailed descriptions of the units 312,314, 316 and data 318-322 are provided below in paragraphs related toFIGS. 12-24 .

FIGS. 12-16 illustrate processing steps performed by the stomal openingcutting unit 312. FIG. 12 shows that the accessory device 8 is used inconnection with the ostomy appliance 2 configured to be placed on a userhaving a stoma 324. The accessory device 8 includes a display device308. Before applying the ostomy appliance 2 to the stoma 324, the camera304 captures one or more images of the user's stoma 324, and theprocessor 300 processes the images using the stomal opening cutting unit312. The stomal opening cutting unit 312 receives the images from thecamera 304 and identifies the stoma 324.

The stoma 324 on the images can be identified based on an objectrecognition algorithm that is tolerant of variation in appearance,object scale, rotation and pose. Accurate detection of the stoma 324 maybe achieved by the stomal opening cutting unit 312 using objectrecognition algorithms using the appearance-based and/or feature-basedmethod. Other suitable object recognition methods are contemplated tosuit the application. Visual cognition algorithms for recognizing thesize and shape of the stoma 324 can be employed using computer visiontechniques, such as Speeded-Up Robust Features (SURF) andScale-Invariant Feature Transform (SIFT). Other suitable techniques arealso contemplated to suit different applications in the stomal openingcutting unit 312.

In at least some embodiments, the stoma 324 (and/or the two referencelocations 354, 356 discussed below) included an image can be identifiedusing machine learning. For example, the stomal opening cutting unit 313can include a convolution neural network module 313 to identify thereference locations 354, 356, the stoma 324, the ostomy appliance 2,and/or the like (e.g., skin redness). The reference locations 354, 356,the stoma 324, the ostomy appliance 2, and/or other objects included inan image may be referred to herein as features of an image.

Initially, the convolution neural network module 313 may be configuredwith weights of the filters used in the convolution neural networkmodule 313 from a pretrained high performing network. In at least someembodiments, each weight value for a filter can correspond to a pixelvalue (e.g., RGB value, HEX code, etc.) of the filter. However, this isonly an example and not meant to be limiting. Additionally oralternatively, the convolution neural network module 313 can be trained,as explained below, on a dataset of images that are of the same ostomistor different ostomists. The images may be captured from the same angleor different angles, in the same lighting or different lighting, andusing different cameras 304. Preferably, the images used to train theneural network module 313 are captured from different angles indifferent lighting using different cameras.

After inputting images into the initial convolution neural networkmodule 313, the convolution neural network module 313 will outputidentified features based on the initial weights. In at least someembodiments, the convolution neural network module 313 will output arespective mask for each identified feature (e.g., the referencelocations 354, 356, the stoma 324, the ostomy appliance 2). Theoutputted identified features can then be compared against known,verified, and/or confirmed features in the images. Similarly, the known,verified, and/or confirmed features may be represented by masks. In atleast some embodiments, the known, verified, and/or confirmed featuresbe manually identified by e.g., one or more humans labeling each of thefeatures in the images.

After the initial convolution neural network module 313 outputsidentified features, the initial weights of the convolution neuralnetwork module 313 may be adjusted so the features identified by theconvolution neural network module 313 closely align with the known,verified, and/or confirmed features. For example, backpropagation can beperformed on the convolution neural network module 313 to adjust theweights of the filters to minimize the differences between the featuresidentified by the convolution neural network module 313 and the known,verified, and/or confirmed features. Over several training iterations,optimal or otherwise suitable weights can be learned for the filters ofthe convolution neural network module 313 and, therefore, theconvolution neural network module 313 can be sufficiently trained toidentify the reference locations 354, 356, the stoma 324, the ostomyappliance 2, and/or other objects included in an image. For example, asufficiently trained convolution neural network module 313 has obtainedan overall accuracy exceeding 95% when identifying reference locations354, 356, the stoma 324, the ostomy appliance 2.

The stomal opening cutting unit 312 generates indicia 326 representativeof a cutting line for the ostomy appliance 2 as a function of theidentified stoma 324 and provides the indicia 326 to the display device308 for display. The cutting line defines a hole to be formed on theostomy appliance 2 (e.g., base plate 4) for receiving the stoma 324. Theindicia 326 may be a continuous indicium (e.g., a solid line) ordiscontinuous indicia (e.g., a broken line). The indicia 326 can bedisplayed by the display device 308 using any type of visual signs orindications, such as a dotted line, a circle, a special character, andthe like.

The display device 308 can provide a visual display depicting anappliance representation 328 (either an actual image or a virtualgraphical image) and the indicia 326 on the appliance representation. Inone case, the appliance representation 328 can be an actual image of theostomy appliance 2, and the indicia 326 are displayed on top of theactual image of the ostomy appliance 2 for reference. The user can markone or more marks on the base plate 4 of the ostomy appliance 2 usingthe indicia 326 on the actual image. The user can readily cut the holein the base plate 4 of the ostomy appliance 2 with a scissor followingthe marked line prepared based on the indicia 326 as a guide. Also, theuser can cut the hole in the base plate 4 without marking the base platebased on the indicia 326 shown on the actual image as the guide. Usingaugmented reality (AR) techniques, the indicia 326 can be displayed on aportion of a captured image of the ostomy appliance. Similarly, usingvirtual reality (VR) techniques, the indicia 326 can be displayed on aportion of a graphical (e.g., virtual) representation of the ostomyappliance. Any combinations of suitable AR and/or VR techniques are alsocontemplated to suit the application.

During the hole cutting process, the camera 304 may continuously capturea sequence of images of the ostomy appliance 2 including the cut hole sothat the sequence of images are captured while the cut is being made bythe user. Then, the stomal opening cutting unit 312 can identify the cutand provide the user via the display device 308 with the cut guideindicia 326 such that the cut guide indicia 326 can be used as the guidefor the user cutting the hole.

As such, the display device 308 displays the user cut guide indicia 326on a visual representation of the sequence of images of the ostomyappliance 2 including the cut. The cut guide indicia 326 may besuperimposed on the appliance representation (e.g., base plate 4 or bag332) to guide the user. Any of the marks and/or signs shown on thevisual display of the display device 308 can be presented as if they aretranslucent to show underlying objects or surfaces beyond obstructingobjects or materials.

While watching the indicia 326 shown on the actual image of the ostomyappliance 2 on the visual display of the display device 308, the usercan revise the marks on the base plate 4 of the ostomy appliance 2 basedon the indicia 326 on the visual display of the display device 308. Theuser can continue to cut the hole in the base plate 4 of the ostomyappliance 2 with the scissor following the revised line prepared basedon the indicia 326 as the guide. Also, the user can adjust the hole inthe base plate 4 without marking the base plate while watching theindicia 326 shown on the actual image as the guide.

Further, the stomal opening cutting unit 312 can generate a graphicalrepresentation of the ostomy appliance 2 (e.g., of an ostomy bag 332)and store it in the memory 302. In this case, the graphicalrepresentation can be a virtual or simulated image of the ostomyappliance 2, and the indicia 326 can be displayed on top of the virtualimage of the ostomy appliance 2 for reference. The user can be guided bythe accessory device 8 to mark one or more marks on the base plate 4 ofthe ostomy appliance 2 using the indicia 326 displayed on the virtualimage by the display device 308. The user can readily cut the hole inthe base plate 4 of the ostomy appliance 2 with the scissor followingthe marked line prepared based on the indicia 326 as the guide. Also,the user can cut the hole in the base plate 4 without marking the baseplate based on the indicia 326 shown on the virtual image as the guide.

The camera 304 may continuously capture a sequence of images of theostomy appliance 2 including the cut hole so that the sequence of imagesare captured while the cut is being made by the user. The visual displayof the display device 308 can display the user cut guide indicia 326 onthe virtual image. While watching the indicia 326 shown on the virtualimage of the ostomy appliance 2, the user can revise the marks on thebase plate 4 of the ostomy appliance 2 based on the indicia 326 on thevirtual image. The user can continue to cut the hole in the base plate 4of the ostomy appliance 2 with the scissor following the revised lineprepared based on the indicia 326 displayed by the display device 308 asthe guide. Also, the user can adjust the hole in the base plate 4without marking the base plate while watching the indicia 326 shown onthe virtual image displayed by the display device 308 as the guide.Thus, it is advantageous that the cutting line defined by the indicia326 provides a customized cut around the stoma 324 for improved comfortand enhanced fitting of the ostomy appliance 2. The present disclosureadvantageously provides augmented-reality based assistance to the userfor performing the technical task of preparing the ostomy appliance 2for placement on the stoma 324 of the user. Alternatively, the indicia326 may be stored in the memory 302 or any other database accessible tothe accessory device 8, and may be subsequently transmitted to anexternal entity (e.g., a server device 10 of FIG. 1 via network 12) forproviding a customized cut in the ostomy appliance 2. The externalentity can be the server device 10 that may be operated and/orcontrolled by the ostomy appliance manufacturer, such that the ostomyappliance manufacturer can cut the hole in the base plate 4 of theostomy appliance 2 for the user based on the methods disclosed herein.In this way, the base plate 4 can be precut and customized for futureuse of the ostomy appliance 2 specifically manufactured for the user.The base plate 4 can be uniformly precut using a stamp tool (e.g., acustomized hole puncher) based on the transmitted indicia 326.

Instead of performing the customized cut, the user can use predefinedhole indicia 330 shown on the appliance representation of the ostomyappliance 2 presented on the visual display by the display device 308.The predefined hole indicia 330 can be in the form of one or moreconcentric circles (FIG. 15 ) presented on the visual display by thedisplay device 308. The predefined hole indicia 330 may be a defaultcutting line for the ostomy appliance 2 for the user. The concentriccircles 330 can be displayed on the actual image of the ostomy appliance2 or the virtual image of the ostomy appliance 2 presented on the visualdisplay by the display device 308. In either case, the user can chooseone of the concentric circles 330 displayed on top of the actual orvirtual image of the ostomy appliance 2 that best matches the user'sstoma 324 based on the indicia 326 and cut the chosen circle with thescissor. The images of the ostomy appliance 2 including the predefinedhole indicia 330 can be stored in the memory 302 or any other databaseaccessible to the accessory device 8.

FIG. 13 shows the two-part ostomy appliance 2 having an ostomy bag 332that is being applied to the stoma 324 of the user. In FIG. 13 , thebase plate 4 includes a release liner 206 that can be peeled off by theuser prior to applying the base plate 4 on the skin. A distal surface206A of the release liner 206 can be attached to the user. Although thetwo-part ostomy appliance 2 is shown, other suitable types ofappliances, such as one-part ostomy appliances, are also contemplated.The camera 304 captures one or more images of the ostomy appliance 2 sothat the visual display of the display device 308 can display at leastportions of the captured image of the ostomy appliance 2, and theindicia 326 on the at least portions of the captured image of the ostomyappliance. When a two-part ostomy appliance is used, the base plate 4can be shown as the captured image of the ostomy appliance 2. When aone-part ostomy appliance is used, the ostomy bag 332 can be shown asthe captured image of the ostomy appliance 2. The captured image of theostomy appliance 2 can also include the predefined hole indicia 330 ofFIG. 15 .

FIG. 14 shows an illustrative screen of the visual display of thedisplay device 308 displaying the stoma 324 taken by the user using thecamera 304. The stoma 324 on the user's body can be displayed on thescreen for image processing. All object recognition and image processingalgorithms described above including the appearance-based and/orfeature-based method can be generally applied to all relevant stepsdiscussed throughout the present disclosure.

The stomal opening cutting unit 312 can identify parametersrepresentative of a perimeter 334 of the stoma 324. The parameters canbe determined based on at least one of: shape, location, size, andorientation information of the stoma 324. The parameters can bedetermined based on the calibration data 318. The parametersrepresenting an outline of the stoma 324 may be calculated usinginformation related to circumferential edges around the stoma 324. Thestomal opening cutting unit 312 can generate the indicia 326representative of the cutting line as a function of the identifiedparameters. The stomal opening cutting unit 312 can process the imagesof the stoma 324 to identify parameters including one or more of sizeand shape of the stoma 324 for facilitating proper cutting of the holein the base plate 4.

FIG. 15 shows an illustrative screen of the visual display on thedisplay device 308 depicting the indicia 326 and a virtual stoma 340(e.g., a user interface object representative of the actual stoma 324)representing the perimeter 334 (presented in FIG. 14 ) of the user'sstoma 324 in a relative scale for display purposes. When the actualstoma 324 is hidden or obstructed by the bag 332, the virtual stoma 340can be displayed by the display device 308 in lieu of the actual stoma324. The visual display of the display device 308 can also show aportion of the base plate 4 having the stoma-receiving opening 18defined by the indicia 326 for the virtual stoma 340.

FIG. 16 shows an illustrative screen of the visual display of thedisplay device 308 depicting the stoma-receiving opening 18 of the baseplate 4. The camera 304 captures an image of the ostomy appliance 2 anda cut hole, such as the stoma-receiving opening 18, in the base plate 4of the ostomy appliance 2. The stomal opening cutting unit 312identifies the cut hole 18 based on the image and compares the cut hole18 to the cutting line represented by the indicia 326, which can beshown in real-time on the visual display of the display device 308 forthe user.

The comparison of the cut hole 18 and the cutting line represented bythe indicia 326 may be performed using a least-squares method to findthe best fit for the user's stoma 324. To show the comparison, thevisual display of the display device 308 may continuously provide theindicia 326 indicating one or more of accuracy of the cut, progress ofthe cut, and completion of the cut while the cutting is performed by theuser. The comparison can also be shown after the cutting has beencompleted by the user.

The stomal opening cutting unit 312 can provide instructions to thedisplay device 308 to display an indicator representative of an accuracyof the cut hole 18 with respect to the cutting line represented by theindicia 326. The accuracy of the cut indicates a degree of closeness tothe cut guide indicia 326 relative to the actual hole cut by the user.As shown in FIG. 18B, the accuracy of the cut can be shown on the visualdisplay of the display device 308 with a traffic light having red 344,yellow 346, and green 348 lights, where the red may indicate an impropercut, the yellow may indicate an acceptable but undesirable cut, and thegreen may indicate a proper cut. Also, at least a portion of the cutguide indicia 326 (FIG. 17 ) can be highlighted in red, yellow, andgreen to indicate the degree of closeness to the cut guide indicia 326in comparison with the actual hole cut by the user. A numericalindication between 0 and 10 showing the degree of closeness is alsocontemplated to suit different applications. The number 0 may indicatethe worst cut and the number 10 may indicate the best cut.

When an unacceptable accuracy of the cut is indicated by the red light344, the user can correct the cutting line using the indicia 326 on thevisual display of the display device 308 as the guide. Since each light(red, yellow, or green) indicates how far the mark is off from thecutting line is off the indicia 326, the user can easily recognizedeviation from the indicia 326 and properly fix the cutting line.

The stomal opening cutting unit 312 can also be configured to indicateto the display device 308 to display a progress and completion ofcutting the hole 18 with respect to the cutting line represented by theindicia 326. The progress of the cut indicates a degree of advancementof a cutting process performed by the user. A progress bar forvisualizing the progression of the cutting process can be displayed onthe visual display of the display device 308. Other suitable progresselement, such as a percentage of the cutting process completed, can alsobe shown. The completion of the cut indicates a conclusion of thecutting process. The display device 308 may be configured to display atextual or graphical sign to notify the user of the conclusion of thecutting process. Other suitable signs, such as audible warnings for thecompletion of the cut, are also contemplated.

The stomal opening cutting unit 312 can receive the calibration data318. The calibration data 318 can be representative of the size of theuser's stoma 324. The calibration data 318 can be provided by theappliance calibration unit 316. The stomal opening cutting unit 312 cangenerate the indicia 326 as a function of the calibration data 318. Thecut guide indicia 326 may be generated based on the calibration data 318associated with the stoma 324. The stomal opening cutting unit 312 canreceive the calibration data 318 through a graphical user interface,e.g., by instructing the display device 308 to receive the calibrationdata 318 from the user using the visual display of the display device308. Similarly, the stomal opening cutting unit 312 can also receive thecalibration data 318 through the input device 306, such as a keyboard.The appliance calibration unit 316 may capture an image of a scale 358(FIG. 20 ) having predetermined dimension indicia with the captured oneor more images of the user's stoma 324, and process the image of thescale 358 to generate the calibration data 318. Detailed descriptions ofthe appliance calibration unit 316 are provided below in paragraphsrelated to FIGS. 19-21 .

FIGS. 17-18B illustrate processing steps performed by the applianceguidance unit 314 during a fitting process of the ostomy appliance 2,e.g., after the hole has been made by the user and the user is providedassistance to place the ostomy appliance 2. FIG. 17 shows the ostomyappliance 2 being applied to the stoma 324 and the accessory device 8having a visual display of the display device 308 depicting the ostomyappliance 2 and indicia 326 during the fitting process. In FIGS.18A-18B, the visual display of the display device 308 can display thefitting process performed by the appliance guidance unit 314 while theostomy appliance 2 is being applied to the stoma 324. The applianceguidance unit 316 is configured to guide the placement of the ostomyappliance 2 on the user having the stoma 324 by providing instructionsto the display device 308. The camera 304 captures an image or asequence of images of the user applying the ostomy appliance 2 to theuser's body. The display device 308 is configured to provide a visualdisplay that can display an image of at least a portion of the actualostomy appliance 2 from one or more of the captured image or sequence ofimages during the fitting process of the ostomy appliance 2 to theuser's stoma 324.

As shown in FIGS. 18A and 18B, the ostomy appliance 2 can include thebase plate 4 and the bag 332. The base plate 4 and the bag 332 can beintegrally formed as a single unit or can be separate units detachableby the user as needed. The appliance guidance unit 316 can generatelocation indicia representative of the location of the ostomy appliance2 with respect to the stoma 324 in one or more of the captured image orsequence of the images, and provide the location indicia in one or moreof the captured image or sequence of the images in the visual display ofthe display device 308. The location indicia can include a stomalocation representation and an appliance location representation. Thestoma location representation may represent a desired location of theostomy appliance 2, and the appliance location representation mayrepresent a current location of the ostomy appliance 2.

The stoma location representation can be an actual location of theactual stoma 324 when it is visible in the captured image or sequence ofthe images. The actual location of the stoma 324 can be identified basedon the object recognition algorithm using a two dimensional plane havingX-axis and Y-axis in the Cartesian coordinate system relative to theuser's body. Other spatial recognition algorithms using a threedimensional space are also contemplated. The appliance guidance unit 316identifies a location of the ostomy appliance 2 in one or more of thecaptured image or sequence of images using similar techniques. Theappliance guidance unit 316 provides the location of the ostomyappliance 2 in one or more of the captured image or sequence of imagesto the display device 308, which in turn displays the stoma locationrepresentation.

When the actual stoma 324 is hidden or obstructed by the bag 332, thestoma location representation can be a calculated location of thevirtual stoma 340. The calculated location of the virtual stoma 340 canbe determined based on at least one mark on the user's body and thecalibration data 318 having the location data 321.

The appliance location representation can be a current location of a cutline 327. The cut line 327 may represent the hole cut by the user withrespect to the stoma 324. To perform the alignment, the cut line 327 canbe moved close to the actual stoma 324 or the virtual stoma 340. Duringthe alignment, the comparison of the actual stoma 324 (or the virtualstoma 340) to the cut line 327 may be performed using the least-squaresmethod to find the best location for the ostomy appliance 2. Thecomparison may be provided to the display device 308 for display.

Also, the stoma location representation can be a desired location 341 ofthe cut line 327. The desired location 341 of the cut line may representa target location of the ostomy appliance 2 with respect to the actualstoma 324 or the virtual stoma 340. The appliance locationrepresentation can be the current location of the cut line 327. Toperform the alignment, the cut line 327 can be moved close to thedesired location 341 of the cut line. During the alignment, thecomparison of the desired location 341 of the cut line to the currentlocation of the cut line 327 may be performed using the least-squaresmethod to find the best location for the ostomy appliance 2.

Further, the stoma location representation can be a desired location 338of the bag 332 (FIG. 18A). The desired location 338 of the bag 332represents a target location of the ostomy appliance 2 with respect tothe actual stoma 324 or the virtual stoma 340. The appliance locationrepresentation can be a current location of the bag 332. To perform thealignment, the current location of the bag 332 can be moved close to thedesired location 338 of the bag.

Similarly, the stoma location representation can be a desired location339 of the base plate 4 (FIG. 18B). The desired location 339 of the baseplate may represent a target location of the ostomy appliance 2 withrespect to the actual stoma 324 or the virtual stoma 340. The appliancelocation representation can be a current location of the base plate 4.To perform the alignment, the current location of the base plate 4 canbe moved close to the desired location 339 of the base plate.

At least a portion of an outer periphery of the bag 332 or base plate 4can be highlighted in red, yellow, and green to indicate the degree ofcloseness to the desired location 338 of the bag or the desired location339 of the base plate. The red may indicate an improper alignment, theyellow may indicate an acceptable but undesirable alignment, and thegreen may indicate a proper alignment. A numerical indication between 0and 10 showing the degree of closeness to the location indicia 338 isalso contemplated to suit different applications. The number 0 mayindicate the worst alignment and the number 10 may indicate the bestalignment. Other displayed objects can also similarly employ thecoloring or numerical indication techniques.

As another alternative or additional way of alignment, the stomalocation representation can be a target location indicia 352representative of a desired location of the ostomy appliance 2. Theappliance location representation can be a current location indicia 353representative of a current position of the ostomy appliance 2. Toperform the alignment, the current location indicia 353 can be movedclose to the target location indicia 352.

More specifically, the appliance guidance unit 316 may provide thetarget location indicia 352 representative of a desired position of theostomy appliance 2 on the user, and the current location indicia 353representative of a current position of the ostomy appliance 2 on theuser. The target and current location indicia 352, 353 can include anyvisible object, such as a character, a geometrical shape, a linesegment, or the like. The visible object can be a circle, a specialcharacter, or a perimeter.

The target location indicia 352 may represent a center of the stomalocation representation, such as the actual stoma 324 or the virtualstoma 340, and the current location indicia 353 may represent a centerof the appliance location representation. The current location indicia353 can be associated with the bag 332 or the base plate 4 of the ostomyappliance 2. As the ostomy appliance 2 is oriented for alignment, thecurrent location indicia 353 can move closer to the target locationindicia 352 for proper alignment of the cut line 327 on the user's stoma324. The target and current location indicia 352, 353 can besuperimposed when they are in close proximity or at the same position.Additional orientation displacements, such as rotations, may be requiredto properly align the cut line 327 with the stoma 324.

During the alignment, the comparison of the target location indicia 352and the current location indicia 353 may be performed using theleast-squares method to find the best location for the ostomy appliance2. To show the comparison, the visual display of the display device 308may continuously provide the target and current location indicia 352,353 indicating one or more of accuracy of the alignment, progress of thealignment, and completion of the alignment while the alignment isperformed by the user. The comparison can also be shown after thealignment has been completed by the user.

At least a portion of the target location indicia 352 can be highlightedin red, yellow, and green to indicate the degree of closeness to thetarget location indicia 352 in comparison with the current locationindicia 353. The red may indicate an improper alignment, the yellow mayindicate an acceptable but undesirable alignment, and the green mayindicate a proper alignment. Also, the numerical indication between 0and 10 showing the degree of closeness to the target location indicia352 is also contemplated to suit different applications. The number 0may indicate the worst alignment and the number 10 may indicate the bestalignment. The visual display of the display device 308 can also showother graphics to show the accuracy, progress, or completion of thealignment with respect to the current location indicia 353.

Any of the methods discussed above can be performed with actual and/orgraphical representations displayed on the visual display of the displaydevice 308 depending on the application. By way of example, the virtualstoma 340 can be used in lieu of the actual stoma 324, or the graphicalrepresentation of the bag 332 or the base plate 4 can be used in lieu ofthe actual image of the bag or the base plate.

To further guide the user for a proper alignment of the ostomy appliance2 in real-time, the appliance guidance unit 316 may generate a qualityindicator 342 representative of a current position of the ostomyappliance 2 with respect to a desired position related to the stoma 324.The quality indicator 342 can be associated with the bag 332 and/or thebase plate 4 of the ostomy appliance 2. The quality indicator 342 may beindicative of a degree of deviation of the ostomy appliance 2 from thestoma 324 (or the virtual stoma 340).

The visual display of the display device 308 can display a visualdisplay of the quality indicator 342 resembling a traffic light havingred 344, yellow 346, and green 348 lights, each of which is selectivelyhighlighted based on a quality of fitting. During alignment, each lightmay indicate a degree of deviation from the stoma 324 (or the virtualstoma 340). The red may indicate an improper alignment, the yellow mayindicate an acceptable but undesirable alignment, and the green mayindicate a proper alignment. The degree of deviation can be determinedusing variance algorithms used in computational statistics forindicating a difference between a current position and a desiredposition, such as the first and current location indicia 352, 353.

Other suitable indicators, such as numeric values between 0 and 10, arealso contemplated to suit different applications. The number 0 mayindicate the worst fit and the number 10 may indicate the best fit. Thelocation indicia 338 itself may be lighted in different colors toindicate the quality of fitting. Alternatively, the graphicalrepresentations representing the current or desired position, such asthe target or current location indicia 352, 353, may be highlightedseparately or simultaneously in different colors to indicate the qualityof fitting. Other suitable combinations of the indicators are alsocontemplated.

The appliance guidance unit 316 can generate the location indicia in theform of a direction indicator 350 representative of an orientation andposition direction with respect to the ostomy appliance 2 that should bemoved to locate the ostomy appliance 2 at a desired position withrespect to the stoma 324. The direction indicator 350 can be associatedwith the orientation and position direction of the bag 332 and/or thebase plate 4. Guided by the direction indicator 350, the user can simplymove the bag 332 and/or the base plate 4 toward the stoma 324. In lieuof the stoma 324, the virtual stoma 340 can be used when the stoma 324is covered by the bag 332.

The visual display of the display device 308 can display the directionindicator 350 in different or highlighted colors to guide the user forproper alignment of the ostomy appliance 2. The direction indicator 350can include multiple directions, e.g., up, down, right, left, and thelike. When the up direction indicator is lighted, the user can upwardlymove the ostomy appliance 2 toward the target location indicia 352. Whenthe down direction indicator is lighted, the user can downwardly movethe ostomy appliance 2 toward the target location indicia 352.

As similarly discussed above, at least a portion of the directionindicator 350 can be highlighted in red, yellow, and green to indicatethe degree of closeness to the desired location of the ostomy appliance2. The red may indicate an improper position, the yellow may indicate anacceptable but undesirable position, and the green may indicate a properposition. Also, the numerical indication between 0 and 10 showing thedegree of closeness to the desired location is also contemplated to suitdifferent applications. The number 0 may indicate the worst position andthe number 10 may indicate the best position.

Also, rotation indicators can be used in combination with the directionindicator 350. Other suitable animated indicators are also contemplatedto suit different applications. Advantageously, the appliance guidanceunit 316 can generate and instruct the display device of the displaydevice 308 to display a graphical simulation of the stoma 324 and theostomy appliance 2 for aiding the user to properly apply the ostomyappliance 2 to the user's body with less difficulty or discomfort.

The appliance guidance unit 314 can receive the calibration data 318representative of the location of the stoma 324 on the user's body withrespect to a reference indicator (e.g., reference locations 354, 356 inFIG. 19 ) on the user's body that is visible in one or more of thecaptured image or sequence of images. The appliance calibration unit 316can identify the reference indicator on the user's body, and alsoidentify the location of the stoma 324 as a function of the identifiedreference indicator on the user's body and the calibration data 318. Theappliance calibration unit 316 can identify the reference indicator onthe ostomy appliance 2. Detailed descriptions of the calibration data318 and the appliance calibration unit 316 are provided below inparagraphs related to FIGS. 19-21 .

FIGS. 19-21 illustrate processing steps performed by the appliancecalibration unit 316 configured to calculate an actual size of the stoma324 based on distance scale information 358. In FIG. 19 , at least tworeference locations associated with the stoma 324, namely a firstreference location 354 and a second reference location 356, are used todetermine the distance scale information 358. The distance scaleinformation 358 representative of a distance D between the two referencelocations 354, 356 is used to calculate the actual size of the stoma324. More specifically, the appliance calibration unit 316, using thecamera 304, captures an image of the stoma 324 with the first referencelocation 354 and the second reference location 356 to determine thedistance D between the first and second reference locations 354, 356.

FIG. 20 shows an illustrative screen of the visual display of thedisplay device 308 depicting the stoma 324 with at least two referencelocations 354, 356. The at least two reference locations 354, 356 arespaced-apart marks located on the user's body and/or on the ostomyappliance 2. The appliance calibration unit 316 is configured tocapture, using the camera 304, an image of a portion of a user's bodythat includes the user's stoma 324 and the at least two referencelocations 354, 356. At least one of the reference locations 354, 356 mayinclude a feature of the user's body at a location spaced apart from thestoma 324 to determine the stoma location data 321 with respect to thefeature of the user's body. When only one feature is available on theuser's body, the location of the stoma 324 can be determined based onthe stoma location data 321 and the one feature on the user's body. Inthis case, from the feature identified on the user's body, the applianceguidance unit 316 can determine an exact location of the stoma 324 usingthe stoma location data 321 and/or the stoma orientation data 320.

The at least two reference locations 354, 356 may include at least twospaced-apart features of the user's body. The first reference location354 may be a birthmark, mole, blemish, nevus, or any other remarkablesymbol disposed on the user's body. The second reference location 356may be a navel or belly button. When such marks are not present on theuser's body, the user can also draw two distinct marks as the tworeference locations on the user's body using a writing instrument. Anyother suitable marks on the user's body recognizable by the camera 304are contemplated.

Any portions of the user's stoma 324 can also be the two referencelocations. The at least two reference locations 354, 356 may include atleast two spaced-apart features of the user's stoma 324. Any portion ofthe stoma 324 can be the reference location. A distance D′ defined byany two points 354′, 356′ disposed on an outermost peripheral edge ofthe stoma 324 may be the two reference locations.

Further, the two reference locations may be any portions on the ostomyappliance 2. Any portions of the ostomy appliance 2 may be the tworeference locations. For the base plate 4, any portions of outermostperipheries of the base plate 4 can be the reference locations. Also,any predetermined marks printed on the base plate 4 can also be thereference locations. Similarly, any portions of outermost peripheries ofthe bag 332 can be the reference locations. Also, any predeterminedmarks printed on the bag 332 can also be the reference locations. In theabsence of the predetermined marks, the user can draw two distinct markson the base plate 4 or the bag 332 using the writing instrument.

As shown in FIG. 21 , the two reference locations can be two marks 354A,356A on the user's body. The two marks 354A, 356A can be on the releaseliner 206 removable from the ostomy appliance 2. The two marks 354A,356A can be predetermined marks printed on the release liner 206 (FIG.13 ) or drawn by the user. The release liner 206 can be peeled off bythe user from the ostomy appliance 2 and adhesively attached to theuser's body.

The at least two reference locations may include at least one feature ofthe user's body (e.g., the birthmark, mole, blemish, nevus, or the like)and at least one mark applied to the user's body (e.g., drawn by theuser using the pen). The at least one mark can include at least one markon the substrate 206 positioned on the user's body that was removed fromthe ostomy appliance 2 and adhesively attached to the user's body. Assuch, any combinations of marks on the user's body and/or the ostomyappliance 2 including the bag 332 and the base plate 4 can be used astwo reference locations to suit different applications.

When the two reference locations 354, 356 are identified, the appliancecalibration unit 316 can receive the distance scale information 358representative of the distance D either on the imaged ostomy appliance 2or on the user's body through a user interface, such as the input device306. The user may enter an actual size of the distance D in a numericalvalue (e.g., 3 inches) using a keyboard. To determine the actual size,the application calibration unit 316 may count a number of pixelsdisposed between the two reference locations 354, 356. The applicationcalibration unit 316 can proportionally extrapolate a pixel ratiorelative to the entered size to calculate the distance of any tworeference locations of the stoma 324. Using this extrapolationtechnique, the application calibration unit 316 can generate thecalibration data 318. In at least some embodiments, the images may bescaled to an image size having the same number of pixels, e.g., 256×256.Then, using the distance scale information 358, each pixel maycorrespond to a physical distance (e.g., x square centimeters, etc.)Additionally or alternatively, each pixel may be assigned an x, ycoordinate to facilitate describing the locations of different featuresin images (e.g., the reference locations 354, 356, the stoma 324, theostomy appliance 2, and/or the like) and their relative positions to oneanother.

However, the distance scale information 358 can also be automaticallyretrieved from an external database or storage. As shown in FIG. 21 ,the camera 304 can capture an image of the ostomy appliance 2 thatincludes at least two reference locations 354A, 356A and determine thedistance D between the at least two reference locations 354A, 356A onthe image of the ostomy appliance 2 by accessing the stored distancescale information 358 in the memory 302 or any other storages.

The application calibration unit 316 can identify a machine-readablecode 360 recognized by the camera 304, and automatically retrieve thedistance scale information 358 based on the code 360 from the externaldatabase or storage, such as the memory 302. A manufacturer of theostomy appliance 2 may insert the distance scale information in thememory 302. The machine-readable code 360 may be a barcode or anyoptical code representing a product identification of the ostomyappliance 2. As known in the art, the barcode can be disposed on anypart of the ostomy appliance 2, such as the base plate 4 or bag 332. Thebarcode can represent a model number of the ostomy appliance 2 havinginformation associated with a reference dimension of the ostomyappliance 2 including the distance D. As discussed above, theapplication calibration unit 316 can proportionally extrapolate thedistance scale information 358 to generate the calibration data 318.

The appliance calibration unit 316 can store distance scale information358 representative of the distance D between the two reference locations354, 354′, 354A (collectively 354) and 356, 356′, 356A (collectively356) in the memory 302. Based on the distance scale information 358, theappliance calibration unit 316 can generate the calibration data 318representative of one or more stoma parameters as a function of theidentified reference locations 354, 356, identified stoma 324 and thedistance scale information 358. The stoma parameters may includeinformation related to one or more of size, orientation, location, andshape data associated with the stoma 324. The application calibrationunit 316 is configured to generate the calibration data 318representative of a location of the stoma 324 with respect to thefeature of the user's body as a function of the identified referencelocations 354, 356, identified stoma 324 and the distance scaleinformation 358.

The calibration data 318 can include one or more of stoma size data 319,stoma orientation data 320, stoma location data 321, and stoma shapedata 322. The stoma size data 319 may refer to information associatedwith an actual or absolute size of the stoma 324. By way of example, anactual size of the stoma 324 may be 2 inches (or 5.08 centimeters). Thestoma orientation data 320 may refer to information associated with arelative physical position or direction of the stoma 324 in relation tothe user's body. The orientation data 320 can be used to rotationallyposition the ostomy appliance 2 at a certain degree as desired.

The stoma location data 321 may refer to information associated with anactual or absolute location of the stoma 324 in relation to the user'sbody. The stoma location data 321 can be used to properly position theostomy appliance 2 on the stoma 324. The stoma shape data 322 may referto information associated with external appearance characteristics ofthe stoma 324. The stoma shape data 322 can be used to determine ageometric shape of the stoma 324, such a round shape.

The application calibration unit 316 can determine and generate the sizedata 319 representative of a size of the stoma 324 as a function of theidentified reference locations 354, 356, identified stoma 324 and thedistance scale information 358. Using the extrapolation techniquediscussed above, the application calibration unit 316 can calculate thesize of the stoma 324. The application calibration unit 316 may useextrapolation algorithms to accelerate the calculation of the stoma sizeusing any two reference locations on the perimeter 334 of the stoma 324.A recursive algorithm for implementing the calculation of the stoma sizemay be employed to go beyond the original calculation range.

The application calibration unit 316 can also determine the orientationdata 320 representative of an orientation of the stoma 324 with respectto at least one of the reference locations 354, 356, and generate theorientation data 320 representative of an orientation of the stoma 324as a function of the identified reference locations 354, 356, identifiedstoma 324 and the distance scale information 358.

The application calibration unit 316 can also determine and generate thelocation data 321 representative of a location of the stoma 324 withrespect to at least one of the reference locations 354, 356. Theapplication calibration unit 316 can determine and generate the shapedata 322 representative of a shape of the stoma 324 as a function of theidentified reference locations 354, 356, identified stoma 324 and thedistance scale information 358. The appliance calibration unit 316 canstore the calibration data 318, the size data 319, the orientation data320, the location data 321, and the shape data 322 in the memory 302 orany other suitable storage to suit the application.

FIG. 22 illustrates one example of a hole cutting method 400 for cuttinga hole in the ostomy appliance 2 (e.g., a method for preparing an ostomyappliance for application). It will be described with reference to FIGS.1-21 . However, any suitable structure can be employed. Although threesub-blocks 402-406 are illustrated, other suitable sub-blocks can beemployed to suit different applications.

In operation, at block 402, the camera 304 can capture one or moreimages of the user's stoma 324. At block 404, the stomal opening cuttingunit 312 can process the images by identifying the stoma 324. The stomalopening cutting unit 312 can receive the images from the camera 304, andperform an object recognition algorithm to accurately identify the stoma324. An appearance-based and/or feature-based method can be used toidentify the stoma 324 in the images.

The stomal opening cutting unit 312 can generate the indicia 326representative of a cutting line for the ostomy appliance 2 as afunction of the identified stoma 324. The cutting line may define a hole(e.g., a stoma opening) to be formed on the ostomy appliance 2 (e.g.,base plate 4) for receiving the stoma 324. The cutting line can bedetermined based on the calibration data 318 having the size data 319and the shape data 322 associated with the stoma 324. The calibrationdata 318 can be determined based on the distance scale information 358using two reference locations 354, 356. At block 406, the display device308 can provide a visual display of the appliance representation 328 andthe indicia 326 on the appliance representation. The appliancerepresentation 328 may be the actual image of the ostomy appliance 2,and the indicia 326 may be displayed on top of the actual image of theostomy appliance 2 for reference during the cutting process.Advantageously, the indicia 326 can be provided (e.g., displayed) forthe user while a hole is being cut on the ostomy appliance 2. Othersuitable combinations of method steps described above are contemplated.

FIG. 23 illustrates one example of an appliance placement method 500 forplacing the ostomy appliance 2 on the user, e.g. for assisting the userin placing the ostomy appliance 2. It will be described with referenceto FIGS. 1-21 . However, any suitable structure can be employed.Although three sub-blocks 502-512 are illustrated, other suitablesub-blocks can be employed to suit different applications.

In operation, at block 502, the camera 304 can capture an image or asequence of images of the user applying the ostomy appliance 2 to theuser's body. At block 504, the appliance guidance unit 314 can processthe captured image or sequence of images. The appliance guidance unit314 can receive the captured image or sequence of images, and performthe fitting process using the calibration data 318 representative of alocation of the stoma 324.

Specifically, at block 506, the appliance guidance unit 316 can identifythe location of the stoma 324 in one or more of the captured image orsequence of images using at least two reference locations. The tworeference locations on the user's body or the ostomy appliance 2 can beused to calculate the location of the stoma 324. Alternatively oradditionally, the location of the stoma 324 can be determined based onthe stoma location data 321 and at least one feature on the user's body.In this case, from the feature identified on the user's body, theappliance guidance unit 316 can determine an exact location of the stoma324 using the stoma location data 321.

At block 508, the appliance guidance unit 316 can identify a location ofthe ostomy appliance 2 in one or more of the captured image or sequenceof images. The location of the ostomy appliance 2 can be identifiedbased on the object recognition algorithm. At block 510, the applianceguidance unit 316 can generate appliance location indicia 338representative of the location of the ostomy appliance 2 with respect tothe stoma 324 in one or more of the captured image or sequence ofimages. The appliance location indicia 338 and stoma location indicia340 can be used by the display device 308, for displaying the appliancelocation indicia 338 and stoma location indicia 340 so as to properlyalign the cut line 327 on the stoma 324 or the graphical representationof the stoma 324.

At block 512, the display device 308 can provide a visual display of thelocation indicia 338 associated with one or more of the captured imageor sequence of images. The appliance guidance unit 316 can generate andinstruct the display device 308 to display a graphical simulation of thestoma 324 and the ostomy appliance 2 for aiding the user to properlyapply the ostomy appliance 2 to the user's body using the appliancelocation indicia 338 and stoma location indicia 340.

FIG. 24 illustrates one example of a calibration method 600 forperforming calibration steps for the ostomy appliance 2. It will bedescribed with reference to FIGS. 1-21 . However, any suitable structurecan be employed. Although three sub-blocks 602-614 are illustrated,other suitable sub-blocks can be employed to suit differentapplications.

In operation, at block 602, the camera 304 can capture an image of aportion of a user's body that includes the user's stoma 324 and at leasttwo reference locations 354, 356. At block 604, the appliancecalibration unit 316 can receive the captured image of the user's body,and calculate the calibration data 318 based on the distance scaleinformation 358 representative of the distance D between the tworeference locations 354 and 356, e.g., using the extrapolationtechnique. The calibration data 318 can be determined based on thedistance D. The distance D may be either manually received by the useror automatically retrieved by the appliance calibration unit 316 fromthe storage. The appliance calibration unit 316 can store the distancescale information 358 in the storage.

At block 606, the appliance calibration unit 316 can process thecaptured image. Specifically, at block 608, the appliance calibrationunit 316 can identify the reference locations 354, 356 on the user'sbody using the object recognition algorithm. At block 610, the appliancecalibration unit 316 can identify the stoma 324, e.g., using the objectrecognition algorithm. At block 612, the appliance calibration unit 316can generate the calibration data 318 representative of one or morestoma parameters as a function of the identified reference locations354, 356, identified stoma 324 and the distance scale information 358.The stoma parameters can include information related to at least one of:size, orientation, location, and shape data associated with the stoma324. At block 614, the appliance calibration unit 316 can store thecalibration data 318 in the memory 302. The stored calibration data 318may be used to perform an accurate alignment of the cut line 327 toprovide information for the fitting process performed by the accessorydevice 8.

FIG. 25 shows an exemplary graphical representation of parameter data asa function of time. In this example, the parameter data in the y-axis isin Volts and time is in the x-axis. Curve 1100 shows, as a function oftime, a first parameter data indicative of voltage measured by the firstelectrode pair of the base plate. Curve 1102 shows, as a function oftime, a second parameter data indicative of voltage measured by thesecond electrode pair of the base plate. Curve 1104 shows, as a functionof time, a third parameter data indicative of voltage measured by thethird electrode pair of the base plate. Curves 1108, 1116, 1118 show, asa function of time, fourth primary parameter indicative of voltagemeasured by the fourth electrode pair of the base plate, fourthsecondary parameter indicative of voltage measured by the fourthelectrode and the fifth electrode of the base plate, and fourth tertiaryparameter indicative of voltage measured by the fifth electrode pair ofthe base plate respectively. Curves 1110, 1112, 1114 show, as a functionof time, a gradient of fourth primary parameter indicative of voltagegradient measured by the fourth electrode pair of the base plate, agradient of fourth secondary parameter indicative of voltage gradientmeasured by the fourth electrode and the fifth electrode of the baseplate, and a gradient of fourth tertiary parameter indicative of voltagegradient measured by the fifth electrode pair of the base platerespectively. FIG. 25 shows the upper voltage threshold valuerepresented as curve 1000, the medium voltage threshold valuerepresented as curve 1002, the lower voltage threshold value representedas curve 1004, and curve 1006 is a gradient limit.

Curves 1108, 1116, 1118 as well as curves 1110, 1112, 1114 show that nomoisture is detected at the proximal side of the first adhesive layer bythe fourth electrode pair.

At a time less than 5 h, curve 1100 shows that moisture is detected bythe first electrode pair as the first parameter data crosses the uppervoltage threshold value while curve 1102 shows that moisture is notdetected by the second electrode pair as the second parameter data hasnot crossed the upper voltage threshold value. At this stage, it isdetermined that the ostomy appliance is in a first operating state.

At time between 5 h and 10 h, curve 1102 shows that moisture is detectedby the second electrode pair as the second parameter data crosses theupper voltage threshold value. At this stage, it is determined that theostomy appliance is in a second operating state.

At time around 45 h, curve 1104 shows that moisture is detected by thethird electrode pair as the third parameter data crosses the uppervoltage threshold value. At this stage, it is determined that the ostomyappliance is in a third operating state.

FIG. 26 shows an exemplary graphical representation of parameter data asa function of time. In this example, the parameter data in the y-axis isin Volts and time is in the x-axis. Curve 1202 shows, as a function oftime, a first parameter data indicative of voltage measured by the firstelectrode pair of the base plate. Curve 1204 shows, as a function oftime, a second parameter data indicative of voltage measured by thesecond electrode pair of the base plate. Curve 1200 shows, as a functionof time, a third parameter data indicative of voltage measured by thethird electrode pair of the base plate. Curves 1206, 1208, 1210 show, asa function of time, fourth primary parameter indicative of voltagemeasured by the fourth electrode pair of the base plate, fourthsecondary parameter indicative of voltage measured by the fourthelectrode and the fifth electrode of the base plate, and fourth tertiaryparameter indicative of voltage measured by the fifth electrode pair ofthe base plate respectively. Curves 1212, 1214, 1216 show, as a functionof time, a gradient of fourth primary parameter indicative of voltagegradient measured by the fourth electrode pair of the base plate, agradient of fourth secondary parameter indicative of voltage gradientmeasured by the fourth electrode and the fifth electrode of the baseplate, and a gradient of fourth tertiary parameter indicative of voltagegradient measured by the fifth electrode pair of the base platerespectively. FIG. 26 shows the upper voltage threshold valuerepresented as curve 1000, the medium voltage threshold valuerepresented as curve 1002, the lower voltage threshold value representedas curve 1004, and curve 1006 represents a gradient limit.

Curves 1206, 1208, 1210 as well as curves 1212, 1214, 1216 show thatmoisture is detected at the proximal side of the first adhesive layer bythe fourth electrode pair, the fourth and fifth electrode, and the fifthelectrode pair at a time starting at 60 h until 90 h. As the threeelectrode pairs are triggered as shown by the decreases shown by 1206,1208, 1210 and as the curves 1212, 1214, 1216 show a gradient below 80%,this is indicative of the presence of sweat at the proximal side of thefirst adhesive layer.

At a time of 30 min, curve 1202 shows that moisture is detected by thefirst electrode pair as the first parameter data crosses the uppervoltage threshold value while curve 1204 shows that moisture is notdetected by the second electrode pair as the second parameter data hasnot crossed the upper voltage threshold value. At this stage, it isdetermined that the ostomy appliance is in a first operating state.

At time around 40 h, curve 1204 shows that moisture is detected by thesecond electrode pair as the second parameter data crosses the uppervoltage threshold value. At this stage, it is determined that the ostomyappliance is in a second operating state.

FIG. 27 shows an exemplary graphical representation of parameter data asa function of time. In this example, the parameter data in the y-axis isin Volts and time is in the x-axis. Curve 1300 shows, as a function oftime, a first parameter data indicative of voltage measured by the firstelectrode pair of the base plate. Curve 1302 shows, as a function oftime, a second parameter data indicative of voltage measured by thesecond electrode pair of the base plate. Curve 1304 shows, as a functionof time, a third parameter data indicative of voltage measured by thethird electrode pair of the base plate. Curves 1306, 1308, 1310 show, asa function of time, fourth primary parameter indicative of voltagemeasured by the fourth electrode pair of the base plate, fourthsecondary parameter indicative of voltage measured by the fourthelectrode and the fifth electrode of the base plate, and fourth tertiaryparameter indicative of voltage measured by the fifth electrode pair ofthe base plate respectively. Curves 1312, 1314, 1316 show, as a functionof time, a gradient of fourth primary parameter indicative of voltagegradient measured by the fourth electrode pair of the base plate, agradient of fourth secondary parameter indicative of voltage gradientmeasured by the fourth electrode and the fifth electrode of the baseplate, and a gradient of fourth tertiary parameter indicative of voltagegradient measured by the fifth electrode pair of the base platerespectively. FIG. 27 shows the upper voltage threshold valuerepresented as curve 1000, the medium voltage threshold valuerepresented as curve 1002, the lower voltage threshold value representedas curve 1004, and curve 1006 is a gradient limit.

Curves 1306, 1308, 1310 as well as curves 1312, 1314, 1316 show thatmoisture is detected at the proximal side of the first adhesive layer bythe fourth electrode pair at a time starting at around 25 h. As leakageelectrodes (i.e. the fourth electrode pair, the fourth and fifthelectrode, and the fifth electrode pair) are trigger as shown by thedecreases shown by 1306, 1308, 1310 and as curve 1312, 1314, 1316 show agradient above 80%, this is indicative of the presence of output at theproximal side of the first adhesive layer. This indicate severe leakage.It may be determined that the ostomy appliance is in a sixth operatingstate.

At a time of 5 h, curve 1300 shows that moisture is detected by thefirst electrode pair as the first parameter data crosses the uppervoltage threshold value while curve 1302 shows that moisture is notdetected by the second electrode pair as the second parameter data hasnot crossed the upper voltage threshold value. At this stage, it isdetermined that the ostomy appliance is in a first operating state.

At time around 15 h, curve 1302 shows that moisture is detected by thesecond electrode pair as the second parameter data crosses the uppervoltage threshold value. At this stage, it is determined that the ostomyappliance is in a second operating state.

At time around 30 h, curve 1304 shows that moisture is detected by thethird electrode pair as the third parameter data crosses the uppervoltage threshold value. In an example where the curves 1306, 1308, 1310had not dropped below corresponding thresholds, curve 1304 indicatesthat moisture has reached the third electrode pair, and the presentdisclosure enables determining that the ostomy appliance is in a thirdoperating state.

FIG. 28 shows an exemplary graphical representation of parameter data asa function of time and a whitening zone diameter (e.g. related to aradial thickness of a whitening ring surrounding the stomal opening) asa function of time. FIG. 28 illustrates the moisture propagation in thefirst adhesive layer as a function of time, and illustrates acorrelation between parameter data detected by the first electrode pairand the second electrode pair of the base plate and actual moisture onthe proximal surface of the first adhesive layer of the base plate. Theactual moisture propagation in the first adhesive layer may appear as awhitening zone (e.g. a white ring around the stomal opening) in thefirst adhesive layer. Moisture affects the first adhesive layer in thatthe moisture reacts with the composition of the first adhesive layer toform the white ring around the stomal opening, and thereby reducesadhesive performance of the base plate. FIG. 28 is obtained byexperiments where water is applied from the stomal opening of the basedplate to follow, using the electrodes of the base plate, the radialpropagation of moisture leading to radial erosion of the first adhesivelayer of the base plate.

Curve 1502 shows, as a function of time, a first parameter dataindicative of voltage measured by the first electrode pair of the baseplate. Curve 1504 shows, as a function of time, a second parameter dataindicative of voltage measured by the second electrode pair of the baseplate. Curve 1506 shows a diameter of the white ring as a function oftime. The first parameter data shows a decrease in e.g. voltage measuredby the first electrode pair over time. It is also seen that the voltageof the second electrode pair drops at a later time than when the firstparameter data shows a decrease in e.g. voltage dropped. This correlateswell with the diameter of the white ring which goes from around 25-26 mmwhen the first electrode pair is triggered (e.g. first parameter datashows a decrease) to 38 mm when the second electrode pair is triggered(second parameter data shows a decrease). This corresponds substantiallyto the location of the first electrode pair at twice the first radialdistance R1, and of the second electrode pair at twice the second radialdistance R2.

It is noted that various regions and countries have various routines andrecommendations to support optimal use of an ostomy appliance. Forexample, in regions of Europe, it may be indicated to the user that anostomy appliance with a base plate as disclosed herein is an optimalstate (corresponding to a first operating state) when the radialthickness of the whitening ring is between 0-15 mm (for a user not incompliance with a preferred use), such as between 0-7 mm (for a user incompliance with a preferred use), such as between 0-5 mm (recommended bya nurse).

For example, in Europe, it may be indicated to the user that an ostomyappliance with a base plate as disclosed herein is in suboptimal state(corresponding to a second operating state) and thereby indicate aconsideration to change the base plate when the radial thickness of thewhitening ring is such as between 5-10 mm (recommended by a nurse),between 7 mm and 10 mm (for a user in compliance with a preferred use),and/or between 15 mm and 30 mm (for a user not in compliance with apreferred use).

For example, in Europe, it may be indicated to the user that an ostomyappliance with a base plate as disclosed herein is in a poor state(corresponding to a third operating state) and indicate a request tochange the base plate when the radial thickness of the whitening ring ismore than 10 mm (recommended by a nurse), such as more than 15 mm (for auser in compliance with a preferred use), such as more than 30 mm (for auser not in compliance with a preferred use).

For example, in other regions (e.g. America), it may be indicated to theuser that an ostomy appliance with a base plate as disclosed herein isan optimal state (corresponding to a first operating state) when theradial thickness of the whitening ring is between 0-20 mm (for a usernot in compliance with a preferred use), such as between 0-10 mm (for auser in compliance with a preferred use), such as between 0-10 mm(recommended by a nurse).

For example, in other regions (e.g. America), it may be indicated to theuser that an ostomy appliance with a base plate as disclosed herein isin suboptimal state (corresponding to a second operating state) andthereby indicate a consideration to change the base plate when theradial thickness of the whitening ring is such as between 10 mm and 20mm (recommended by a nurse), between 10 mm and 20 (for a user incompliance with a preferred use), and/or between 20 mm and 40 mm (for auser not in compliance with a preferred use).

For example, in other regions (e.g. America), it may be indicated to theuser that an ostomy appliance with a base plate as disclosed herein isin a poor state (corresponding to a third operating state) and indicatea request to change the base plate when the radial thickness of thewhitening ring is more than 20 mm (recommended by a nurse), such as morethan 20 mm (for a user in compliance with a preferred use), such as morethan 40 mm (for a user not in compliance with a preferred use).

The disclosed methods, ostomy appliances, monitor devices, and accessorydevices allow to accommodate the regional preferences of user in theiruse of the ostomy appliance so as to adjust thresholds for the operatingstates to the regional preference or use.

FIGS. 29A-29B shows exemplary graphical representations of peel force asa function of a peeling distance travelled by a peeling actionexercising the peel force (e.g. perpendicularly to the proximal (ordistal) surface of the first adhesive layer) on a first adhesive layerof a base plate disclosed herein. The peel force relates to a requiredforce to peel the first adhesive layer off the skin surface. The peelingdistance is with respect to one end of the first adhesive layer wherethe peel force starts to be exercised. The peeling distance relates tothe size or length of the first adhesive layer and thereby may relate toa size or length of a portion the first adhesive layer affected bymoisture and of a portion of the first adhesive layer not affected bymoisture. The peel forces illustrated in FIGS. 29A-29B arerepresentative of adhesive performance of the first adhesive layer ofthe base plate to the skin surface.

Composition of the first adhesive layer of the base plate as disclosedherein in one or more embodiments is formulated to provide adhesion ofthe base plate to the skin surface of the user when the base plate isworn and to maintain a dry and healthy skin surface. Avoiding macerationof skin when occluding the skin with an adhesive is done by transportingsweat away from the skin and into the first adhesive layer by means ofe.g. hydrocolloid types and adhesive (e.g. hydrocolloid adhesives)forming part of an absorbing element of the first adhesive layer.

For example, when the absorbing element is in contact with moisture,(e.g. water, sweat, urine or faeces), the absorbing element absorb themoisture. This reduces the adhesion of the first adhesive layer to theskin.

For example, the first adhesive layer goes from a dry adhesive statewith acceptable adhesive performance (e.g. acceptable adhesion andcohesion) in to a wet adhesive state (e.g. reduced or non adhesion andlow cohesion gel).

Curve 1602 of FIGS. 29A and 29B shows a peel force applied to the firstadhesive layer as a function of a peeling distance travelled by apeeling action exercising the peel force on the first adhesive layer ina dry adhesive state, (e.g. not affected by moisture). The peel force isexpressed in Newtons while the peeling distance is expressed in mm. Thelength of the first adhesive layer in dry adhesive state is illustratedby X5, corresponding to length of the first adhesive layer 1608 in dryadhesive state.

Curve 1602 shows that the peel force applied to the first adhesive layerin a dry adhesive state is equal to Y1 when the peeling distance is lessthan X1. At X1, the peeling force drops as the peeling distanceincreases towards X5 and the end of the first adhesive layer.

Curve 1604 of FIG. 29A shows a peel force applied to the first adhesivelayer as a function of a peeling distance travelled by a peeling actionexercising the peel force on the first adhesive layer in a wet adhesivestate, (e.g. affected by moisture to the point of reaching a completelywet adhesive state, where the first adhesive layer has become a gel).

Curve 1604 shows that when the peeling distance is less than X2, thepeel force applied to the first adhesive layer in a wet adhesive stateis equal to Y2 which has much lower value than Y1. This shows that theadhesive performance of the first adhesive layer is reduced when thefirst adhesive layer is in a wet adhesive state. At X2, the peelingforce drops as the peeling distance increases until the end of the firstadhesive layer. It is noted that X2 is larger than X1, because the firstadhesive layer in a wet adhesive state extends in volume, and thus inlength due to the gelling of the components of the first adhesive layer.

The peel experiment illustrated in FIG. 29A shows a loss of adhesiveperformance when the first adhesive is in a wet adhesive state.

Curve 1606 of FIG. 29B shows a peel force applied to the first adhesivelayer as a function of a peeling distance travelled by a peeling actionexercising the peel force on the first adhesive layer illustrated 1610which comprises a first portion 1610A in a dry adhesive state and asecond portion 1610B in a wet adhesive state, (e.g. affected by moistureto the point of reaching a completely wet adhesive state, where thefirst adhesive layer has become a gel).

Curve 1606 shows that when the peeling distance is less than X3, thepeel force applied to the first adhesive layer in a wet adhesive stateis equal to Y3 which has lower value than Y1. This shows that theadhesive performance of the first adhesive layer is reduced when thefirst adhesive layer comprises a portion in a wet adhesive state. At X3,the peeling force drops as the peeling distance increases until the endof the first adhesive layer. It is noted that X3 corresponds to thelength of the portion 1610A in dry adhesive state.

The peel experiment illustrated in FIG. 29B shows a loss of adhesiveperformance when the first adhesive is partly in a wet adhesive state.

Accordingly, FIGS. 29A-29B demonstrate that the operating statedetermined based on monitor data is indicative of adhesive performanceof the base plate.

The above detailed description of the present disclosure and theexamples described therein have been presented for the purposes ofillustration and description only and not by limitation. It is thereforecontemplated that the present disclosure covers any and allmodifications, variations or equivalents that fall within the spirit andscope of the basic underlying principles disclosed above and claimedherein.

The use of the terms “first”, “second”, “third” and “fourth”, “primary”,“secondary”, “tertiary” etc. does not imply any particular order, butare included to identify individual elements. Moreover, the use of theterms “first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. does not denote any order or importance, but rather theterms “first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. are used to distinguish one element from another. Notethat the words “first”, “second”, “third” and “fourth”, “primary”,“secondary”, “tertiary” etc. are used here and elsewhere for labellingpurposes only and are not intended to denote any specific spatial ortemporal ordering. Furthermore, the labelling of a first element doesnot imply the presence of a second element and vice versa.

Although particular features have been shown and described, it will beunderstood that they are not intended to limit the claimed invention,and it will be made obvious to those skilled in the art that variouschanges and modifications may be made without departing from the spiritand scope of the claimed invention. The specification and drawings are,accordingly to be regarded in an illustrative rather than restrictivesense. The claimed invention is intended to cover all alternatives,modifications and equivalents.

LIST OF REFERENCES

1 ostomy system

2 ostomy appliance

4 base plate

6 monitor device

8 accessory device

10 server device

12 network

14 coupling member

16 coupling ring

18, 18A, 18B, 18C, 18D stomal opening

19 center point

20 docking station

22 first connector

24 user interface

100 monitor device housing

101 processor

102 first interface

104 second interface

106 memory

108 ground terminal of monitor device

110 first terminal of monitor device

112 second terminal of monitor device

114 third terminal of monitor device

116 fourth terminal of monitor device

118 fifth terminal of monitor device

120 coupling part

121 power unit

122 antenna

124 wireless transceiver

126 loudspeaker

128 haptic feedback element

140 sensor unit

200 first adhesive layer

200A distal surface of first adhesive layer

200B proximal surface of first adhesive layer

202 second adhesive layer

202A distal surface of second adhesive layer

202B proximal surface of second adhesive layer

204 electrode assembly

204A distal surface of electrode assembly

204B proximal surface of electrode assembly

206 release liner

206A distal surface of the release liner

206B proximal surface of the release liner

208 top layer

208A distal surface of the top layer

208B proximal surface of the top layer

209 coupling ring

210 coupling part of first connector

211 first connector

212 terminals of first connector

213 first intermediate element

213A distal surface of first intermediate element

213B proximal surface of first intermediate element

214 support layer of electrode assembly

214A distal surface of support layer

214B proximal surface of support layer

216 electrodes of electrode assembly

217 connection parts of electrodes

218, 219 masking element

218A distal surface of masking element

218B proximal surface of masking element

220, 220A, 220B electrode configuration

222 ground electrode

222A ground connection part

222B ground sensing part

224 first electrode

224A first connection part

224B first sensing part

226 second electrode

226A second connection part

226B second sensing part

228 third electrode

228A third connection part

228B third sensing part

230 fourth electrode

230A fourth connection part

230B fourth sensing part

232 fifth electrode

232A fifth connection part

232B fifth sensing part

234 first electrode part of the ground electrode

236 second electrode part of the ground electrode

238 third electrode part of the ground electrode

240 fourth electrode part of the ground electrode

242 ground terminal opening

244 first terminal opening

246 second terminal opening

248 third terminal opening

250 fourth terminal opening

252 fifth terminal opening

254 primary sensor point openings of masking element

254A primary first sensor point opening

254B primary second sensor point opening

256 secondary sensor point openings of masking element

256A secondary first sensor point opening

256B secondary second sensor point opening

258 tertiary sensor point openings of masking element

258A tertiary first sensor point opening

258B tertiary second sensor point opening

260 primary sensor point openings of first adhesive layer

260A primary first sensor point opening

260B primary second sensor point opening

262 secondary sensor point openings of first adhesive layer

262A secondary first sensor point opening

262B secondary second sensor point opening

264 tertiary sensor point openings of first adhesive layer

264A tertiary first sensor point opening

264B tertiary second sensor point opening

282 ground terminal element

282A ground terminal

284 first terminal element

284A first terminal

286 second terminal element

286A second terminal

288 third terminal element

288A third terminal

290 fourth terminal element

290A fourth terminal

292 fifth terminal element

292A fifth terminal

300 processor

302 memory

304 camera

306 input device

308 display device

310 bus

312 stomal opening cutting unit

313 convolution neural network module

314 appliance guidance unit

316 appliance calibration unit

318 calibration data

319 size data

320 orientation data

321 location data

322 shape data

324 stoma

326 indicia

327 cut line

328 appliance representation

330 predefined hole indicia

332 ostomy bag

334 perimeter

338 desired location of bag

339 desired location of base plate

340 virtual stoma

341 desired location of cut line

342 quality indicator

344 red light

346 yellow light

348 green light

350 direction indicator

352 target location indicia

353 current location indicia

354 first reference location

356 second reference location

358 distance scale information

360 machine-readable code

400 hole cutting method

402 capture one or more images of the user's stoma

404 process the images by identifying the stoma; and generating indiciarepresentative of a cutting line for the ostomy appliance as a functionof the identified stoma, wherein the cutting line defines a hole to beformed on the ostomy appliance

406 provide a visual display including: an appliance representation; andthe indicia on the appliance representation

500 appliance placement method

502 capture an image or a sequence of images of the user applying theostomy appliance to the user's body

504 process the captured image or sequence of images

506 identify a location of the stoma in one or more of the capturedimage or sequence of images

508 identify a location of the ostomy appliance in one or more of thecaptured image or sequence of images

510 generate location indicia representative of the location of theostomy appliance with respect to the stoma in one or more of thecaptured image or sequence of images

512 provide a visual display including the location indicia associatedwith one or more of the captured image or sequence of images

600 calibration method

602 capture an image of a portion of a user's body that includes theuser's stoma and at least two reference locations

604 store distance scale information representative of a distancebetween the two reference locations

606 process the captured image

608 identify the reference locations

610 identify the stoma

612 generate calibration data representative of one or more stomaparameters as a function of the identified reference locations,identified stoma and the distance scale information

614 store the calibration data

1000 curve representing the upper voltage threshold value

1002 curve representing the medium voltage threshold value

1004 curve representing the lower voltage threshold value

1006 curve representing a gradient limit

1100 curve showing, as a function of time, a first parameter dataindicative of voltage measured by the first electrode pair of the baseplate

1102 curve showing, as a function of time, a second parameter dataindicative of voltage measured by the second electrode pair of the baseplate

1104 curve showing, as a function of time, a third parameter dataindicative of voltage measured by the third electrode pair of the baseplate

1108 curve showing, as a function of time, a fourth primary parameterindicative of voltage measured by the fourth electrode pair of the baseplate

1110 curve showing, as a function of time, a gradient of fourth primaryparameter indicative of voltage gradient

1112 curve showing, as a function of time, a gradient of fourthsecondary parameter indicative of voltage gradient measured

1114 curve showing, as a function of time, a gradient of fourth tertiaryparameter indicative of voltage gradient measured

1116 curve showing, as a function of time, a fourth secondary parameterindicative of voltage measured

1118 curve showing, as a function of time, a fourth tertiary parameterindicative of voltage measured

1200 curve showing, as a function of time, a third parameter dataindicative of voltage measured by the third electrode pair of the baseplate

1202 curve showing, as a function of time, a first parameter dataindicative of voltage measured by the first electrode pair of the baseplate

1204 curve showing, as a function of time, a second parameter dataindicative of voltage measured by the second electrode pair of the baseplate

1206 curve showing, as a function of time, a fourth primary parameterindicative of voltage measured by the fourth electrode pair of the baseplate

1208 curve showing, as a function of time, a fourth secondary parameterindicative of voltage measured

1210 curve showing, as a function of time, a fourth tertiary parameterindicative of voltage measured

1212 curve showing, as a function of time, a gradient of fourth primaryparameter indicative of voltage gradient measured by the fourthelectrode pair of the base plate

1214 curve showing, as a function of time, a gradient of fourthsecondary parameter data indicative of voltage gradient measured

1216 curve showing, as a function of time, a gradient of fourth tertiaryparameter indicative of voltage gradient measured

1300 curve showing, as a function of time, a first parameter dataindicative of voltage measured by the first electrode pair of the baseplate

1302 curve showing, as a function of time, a second parameter dataindicative of voltage measured by the second electrode pair of the baseplate

1304 curve showing, as a function of time, a third parameter dataindicative of voltage measured by the third electrode pair of the baseplate

1306 curve showing, as a function of time, a fourth primary parameterindicative of voltage measured by the fourth electrode pair of the baseplate

1308 curve showing, as a function of time, a fourth seondary parameterindicative of voltage measured

1310 curve showing, as a function of time, a fourth tertiary parameterindicative of voltage measured

1312 curve showing, as a function of time, a gradient of fourth primaryparameter indicative of voltage gradient measured by the fourthelectrode pair of the base plate

1314 curve showing, as a function of time, a gradient of fourthsecondary parameter indicative of voltage gradient measured

1316 curve showing, as a function of time, a gradient of fourth tertiaryparameter indicative of voltage gradient measured

1502 curve showing, as a function of time, a first parameter dataindicative of voltage measured by the first electrode pair of the baseplate

1504 curve showing, as a function of time, a second parameter dataindicative of voltage measured by the second electrode pair of the baseplate

1506 curve showing a diameter of the white ring as a function of time

1602 curve showing peel force applied to the first adhesive layer in adry adhesive state as a function of peeling distance

1604 a peel force applied to the first adhesive layer as a function of apeeling distance travelled by a peeling action exercising the peel forceon the first adhesive layer in a wet adhesive state

1606 a peel force applied to the first adhesive layer as a function of apeeling distance travelled by a peeling action exercising the peel forceon the first adhesive layer partially wet

1608 length of the first adhesive layer 1608 in dry adhesive state

1610 the first adhesive layer which comprises a first portion in a dryadhesive state and a second portion in a wet adhesive state

1610A a first portion in a dry adhesive state

1610B a second portion in a wet adhesive state

R1 first radial distance

RG1 first ground distance

R2 second radial distance

RG2 second ground distance

R3 third radial distance

RG3 third ground distance

The following is claimed:
 1. A method for processing calibration data togenerate a visual indicia based on image data of a stoma, comprising:obtaining, from a camera, image data of a portion of a user's body thatincludes the user's stoma and at least two reference locations;processing the image data to generate calibration data, the processingincluding: identifying the reference locations; identifying the stoma;and generating the calibration data representative of one or more stomaparameters as a function of the identified reference locations,identified stoma, and distance scale information that is representativeof a distance between the two reference locations; and displaying, by anaccessory device, an indicia based on the calibration data that isrepresentative of a cutting line that defines a hole to be formed forreceiving the identified stoma.
 2. The method of claim 1, wherein thecalibration data includes one or more of stoma size data, stomaorientation data, stoma shape data and stoma location data.
 3. Themethod of claim 1, and further including receiving the distance scaleinformation through a user interface.
 4. The method of claim 1, whereinthe at least two reference locations include at least two spaced-apartfeatures of the user's body.
 5. The method of claim 4, wherein the atleast two reference locations include at least two spaced-apart featuresof the user's stoma.
 6. The method of claim 1, wherein the at least tworeference locations are spaced-apart marks applied to the user's body.7. The method of claim 6, wherein the at least two marks include twomarks on a substrate on the user's body.
 8. The method of claim 6,wherein the two marks are on a substrate removed from an ostomyappliance.
 9. The method of claim 1, wherein the two marks are on asubstrate adhesively attached to the user's body.
 10. The method ofclaim 1, wherein the at least two reference locations include: at leastone feature of the user's body; and at least one mark applied to theuser's body.
 11. The method of claim 10, wherein the at least one markincludes at least one mark on a substrate positioned on the user's body.12. The method of claim 11, wherein the at least one mark is on asubstrate removed from an ostomy appliance.
 13. The method of claim 11,wherein the at least one mark is on a substrate adhesively attached tothe user's body.
 14. The method of claim 1, wherein: processing theimage data further includes determining location data representative ofa location of the stoma with respect to at least one of the referencelocations.
 15. The method of claim 1, wherein: processing the image datafurther includes determining orientation data representative of anorientation of the stoma with respect to at least one of the referencelocations.
 16. The method of claim 1, wherein: processing the image datafurther includes determining shape data representative of the shape ofthe stoma.
 17. The method of claim 1, wherein: obtaining image data thatincludes at least two reference locations includes capturing image dataof an ostomy appliance including the at least two reference locations;and the method further includes determining the distance between the atleast two reference locations of the ostomy appliance.
 18. The method ofclaim 17, wherein determining the distance between the at least tworeference locations includes receiving information through a userinterface.
 19. The method of claim 18, wherein: the method furthercomprises storing information representative of the distance betweenreference locations on each of one or more ostomy appliances; receivinginformation through the user interface includes receiving informationassociated with the imaged ostomy appliance; and determining thedistance between the at least two reference locations includes accessingstored distance scale information using the received informationrepresentative of the imaged ostomy appliance.
 20. The method of claim1, wherein: processing the image data further includes determining sizedata representative of the size of the stoma.
 21. The method of claim 1,wherein the accessory device includes the camera, an image processor,and a display device.
 22. The method of claim 1, wherein identifying thereference locations and/or identifying the stoma is performed usingmachine learning.
 23. A method, performed by an accessory device, forprocessing ostomy calibration data, comprising: obtaining, from acamera, an image of a portion of a user's body that includes the user'sstoma and at least two reference locations; storing distance scaleinformation representative of a distance between the two referencelocations; processing the image to generate size data, the processingincluding: identifying the reference locations; identifying the stoma;generating the size data representative of a size of the stoma as afunction of the identified reference locations, identified stoma, andthe distance scale information; and storing the size data; generating,based on the size data, an indicia representative of a cutting line thatdefines a hole to be formed for receiving the identified stoma; anddisplaying, by the accessory device, the indicia to the user.
 24. Amethod, performed by an accessory device, for processing calibrationdata, the accessory device comprising a camera, an image processor, amemory, and a display, the method comprising: capturing, using thecamera of the accessory device, an image of a portion of a user's bodythat includes the user's stoma and at least two reference locationsselected from a group of reference locations including: a feature of theuser's body at a location spaced apart from the stoma; and a markapplied to the user's body; storing distance scale informationrepresentative of a distance between the two reference locations;processing the captured image, including: identifying, using an objectrecognition algorithm, the reference locations; identifying, using theobject recognition algorithm, the stoma; generating calibration data,including one or more of stoma size data, stoma orientation data, stomashape data, and stoma location data, wherein the calibration data isrepresentative of one or more stoma parameters as a function of theidentified reference locations, identified stoma, and the distance scaleinformation; and storing the calibration data; generating, based on thecalibration data, an indicia representative of a cutting line thatdefines a hole to be formed for receiving the identified stoma; anddisplaying, via the display of the accessory device, the indicia to theuser.
 25. The method of claim 24, wherein at least one feature of theuser's body includes a feature of the user's stoma.
 26. A method,performed by an accessory device, for processing ostomy calibrationdata, comprising: obtaining, from a camera, an image of a portion of auser's body that includes the user's stoma and at least two referencelocations; storing distance scale information representative of adistance between the two reference locations; processing the image togenerate shape data, the processing including: identifying the referencelocations; identifying the stoma; generating the shape datarepresentative of a shape of the stoma as a function of the identifiedreference locations, identified stoma and the distance scaleinformation; and storing the shape data; generating, based on the shapedata, an indicia representative of a cutting line that defines a hole tobe formed for receiving the identified stoma; and displaying, by theaccessory device, the indicia to the user.
 27. A method, performed by anaccessory device, for processing ostomy calibration data, comprising:obtaining, from a camera, an image of a portion of a user's body thatincludes the user's stoma and at least two reference locations; storingdistance scale information representative of a distance between the tworeference locations; processing the captured image to generateorientation data, the processing including: identifying the referencelocations; identifying the stoma; generating the orientation datarepresentative of an orientation of the stoma as a function of theidentified reference locations, identified stoma, and the distance scaleinformation; and storing the orientation data; generating, based on theorientation data, an indicia representative of a cutting line thatdefines a hole to be formed for receiving the identified stoma; anddisplaying, by the accessory device, the indicia to the user.